FDA Device recall Z-2949-2018
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 by Depuy Orthopaedics, citing this unit may be missing the screw/collet Assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2949-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Orthopaedics |
| Distribution | n/a |
Product
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Reason
This unit may be missing the screw/collet Assembly
Identifiers
| code_info | Lot: C2KJ24, GTIN: 10603295234135 |
|---|
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-2949-2018%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.