URGENT NOTICE: MEDICAL DEVICE RECALL Synthes Trochanteric Fixation Nailing (TFN) System
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- Bennett Hudson
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1 URGENT NOTICE: MEDICAL DEVICE RECALL Synthes Trochanteric Fixation Nailing (TFN) System Dear Sir/ Madam: Synthes is initiating a voluntary recall of all lots of the Trochanteric Fixation Nailing (TFN) System due to the possibility that the outer pouch may be compromised. This recall is not being undertaken on the basis of adverse events. The issue was identified during a validation test for a change to our sterile packaging. The test revealed there is the potential for damage to the external pouch. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. While the risk of harm to the patient is remote, we are recalling the products as a measure of caution. An improvement to the packaging line has been implemented, and is now in place to help prevent the issue from arising again. Synthes is requesting that you please examine your inventory for all products with the Part numbers listed below. Synthes strongly urges you to return the identified devices and replacement product will be provided once it becomes available. If you have any questions or concerns, please call your Synthes Sales organization. 1 of 9
2 FULL RECALLED PRODUCT LIST: Part Description Part Number Lot Number Trochanteric Fixation Nails See Attached See Attached-Please note, Lot numbers up to and including Lot # are within the scope of this recall. If you DO have any of the identified devices and intend to return them for a replacement, please take the following steps: Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 3 of this letter) with the product to your local Synthes Sales organization. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the document to your Synthes Sales organization. If you have any questions, please contact your Synthes Sales Representative. We apologize for any inconvenience this may cause and thank you in advance for your attention and cooperation. Please contact your Synthes Sales Consultant for additional information as required. Sincerely, Heinz Gribi Manager, Complaint Handling Unit Synthes GmbH 2 of 9
3 Part Description URGENT NOTICE: MEDICAL DEVICE RECALL Synthes Trochanteric Fixation Nailing (TFN) System Verification Section Part Description Part Number Lot Number Trochanteric Fixation Nails See Attached See Attached-Please note, Lot numbers up to and including Lot # are within the scope of this recall I have located the identified product in stock; returned quantity is documented below for replacement. I do not have any identified product in stock; returned quantity is zero. RETURNED DEVICES (including quantity): Name/Title: (please print) Phone Number: Signature and Date: 3 of 9
4 Product Number Product Description Lot Number S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 10MM/125 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER 4 of 9
5 S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 10MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER 10MM/135 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 10MM/135 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER 5 of 9
6 S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 11MM/125 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 11MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER 6 of 9
7 S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 11MM/135 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER 12MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER 12MM/125 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER 7 of 9
8 S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER 12MM/135 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER S S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER S 12MM/125 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 12MM/135 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 320MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER 8 of 9
9 S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/LEFT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/RIGHT-STER S 14MM/130 DEG TI CANN TROCH FIXATION NAIL 460MM/LEFT-STER 9 of 9
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