ASR Hip System Recall Part Code Listing

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1 ASR Hip System Recall Part Code Listing Updated October 19, The following is a complete list of all DePuy ASR recalled part and lot numbers including Acetabular cups, Fem primary heads, Femoral XL modular heads, fem XL anatomic modular heads, ASR 300 cups. 510(k) Cleared Part Number US 510k 510k ASR Acetabular Cups ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE k ASR femoral primary heads (aka hemis) ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE ASR FEMORAL IMPLANT SIZE k ASR fern XL modular heads ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE 51

2 ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE (k) Cleared Part Number US 510k Adapter Sleeves ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 12/ ASR TAP SLV ADAP 12/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 12/ ASR TAP SLV ADAP 12/ k ASR fem XL Anatomic modular heads and tapers (same Int) ASR XLA SML Sleeve 11/ ASR XLA SML Sleeve 11/ ASR XLA SML Sleeve 11/ ASR XLA SML Sleeve 11/ ASR XLA SML Sleeve 11/ ASR XLA STD Sleeve 11/ ASR XLA STD Sleeve 11/ ASR XLA STD Sleeve 11/ ASR XLA STD Sleeve 11/ ASR XLA STD Sleeve 11/ k ASR 300 Cups (same as lnt) ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size 70 Additional Codes ASR ACETABULAR CUPS 64

3 ASR ACETABULAR CUPS (k) Cleared Part Number US 510k ASR ACETABULAR CUPS ASR ACETABULAR CUPS ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE 55 IDE Study (In progress) Part Number US IDE IDE/PMA ASR Acetabular Cups TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE 70 IDE ASR femoral heads obsolete TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE 49

4 TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE 63 PMA ASR femoral heads TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE 63 Codes ASR Acetabular Cups TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE TOTAL ASR ACET IMP SIZE 70 ASR femoral primary heads TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE 47

5 TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE 63 ASR fem modular XL heads ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE ASR UNI FEMORAL IMPL SIZE 63 Codes ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 12/ ASR TAP SLV ADAP 12/ ASR TAP SLV ADAP 9/ ASR TAP SLV ADAP 9/ ASR TAP SLV ADAP 9/ ASR TAP SLV ADAP 11/ ASR TAP SLV ADAP 12/ ASR TAP SLV ADAP 12/ ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size 53

6 ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XL Anatomic Head Size ASR XLA +8 Sleeve 12/ ASR XLA +8 Sleeve 12/ ASR XLA +8 Sleeve 12/ ASR XLA +8 Sleeve 12/ ASR XLA +8 Sleeve 12/ ASR XLA +4 Sleeve 12/ ASR XLA +4 Sleeve 12/ ASR XLA +4 Sleeve 12/ ASR XLA +4 Sleeve 12/ ASR XLA +4 Sleeve 12/ k ASR 300 cups (same as US) ASR 300 Size ASR 300 Size ASR 300 Size 48 Codes ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size ASR 300 Size 70 Additional Codes Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head Modular Femoral Head 60

7 Modular Femoral Head ASR Total Femoral Implant Size 55 RSA ASR Total Femoral Implant Size 49 RSA ASR Total Femoral Implant Size 57 RSA ASR Total Femoral Implant Size 47 RSA ASR Total Femoral Implant Size 51 RSA ASR Total Femoral Implant Size 53 RSA ASR Total Acetabular Implant RSA Size ASR Total Acetabular Implant RSA Size ASR Total Acetabular Implant RSA Size ASR Total Acetabular Implant RSA Size ASR Total Acetabular Implant RSA Size ASR Total Acetabular Implant RSA Size 54 Additional codes ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT 50 codes ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT ASR ACETABULAR IMPLANT TOTAL ASR FEM IMP SIZE Â TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE TOTAL ASR FEM IMP SIZE 61

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