FDA Device recall Z-1077-2014
PFC SIGMA Cruciate Retaining (CR)
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of PFC SIGMA Cruciate Retaining (CR) by Depuy Orthopaedics, citing knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1077-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-09 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | CA, FL, IA, KY |
Product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Reason
Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.
Identifiers
| code_info | Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1077-2014%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.