(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number:… — Class II medical device recall Z-1219-2018
Terminated recall by DePuy Orthopaedics, Inc., reported 2018-04-04, distributed nationwide. The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being reca
| Recall number | Z-1219-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-12-21 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FI, FR, GB, HR, IE, IN, IT, KR, LU, MY, NL, PT, SE, SG, SI, SK, TH, TR, ZA |
| Quantity | 2,110 |
| UPC / GTIN / UDI-DI | 10603295001614, 10603295001621, 10603295001638, 10603295001645, 10603295001652, 10603295001669, 10603295001676, 10603295001683, 10603295001690, 10603295001706 |
| Model numbers | 102403100, 102403200, 102403300, 102403400, 102403500, 102404100, 102404200, 102404300, 102404400, 102404500 |
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; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1219-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.