FDA Device recall Z-1219-2018
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614 by Depuy Orthopaedics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1219-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-21 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.