DePuy Orthopaedics, Inc. Recall: (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalo
DePuy Orthopaedics, Inc. Recall: (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalo is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: DePuy Orthopaedics, Inc.; Product: (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP
| Recalling firm | DePuy Orthopaedics, Inc. |
|---|---|
| Product | (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; |
| Reason for recall | The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and |
| Recall initiated | 20171221 |
| Recall number | Z-1219-2018 |
| Category | device |
| State | IN |
| Country | United States |
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