FDA Device recall Z-1114-2017
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies by Zimmer Biomet, citing labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1114-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, LA, MA, MD, NJ, TX, WA, WI |
Product
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Reason
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
Identifiers
| code_info | Part # Lot # UDI CP113462 646200 (01) 0 0880304 51008 1 (17) 250928 (10) 646200 CP113462 690040 (01) 0 088030…Part # Lot # UDI CP113462 646200 (01) 0 0880304 51008 1 (17) 250928 (10) 646200 CP113462 690040 (01) 0 0880304 51008 1 (17) 260714 (10) 690040 CP113462 003620 (01) 0 0880304 51008 1 (17) 260324 (10) 003620 CP113462 498380 (01) 0 0880304 51008 1 (17) 250929 (10) 498380 CP113462 690050 (01) 0 0880304 51008 1 (17) 260622 (10) 690050 CP113462 539760 (01) 0 0880304 51008 1 (17) 251007 (10) 539760 CP113462 409190 (01) 0 0880304 51008 1 (17) 260417 (10) 409190 CP113462 799300 (01) 0 0880304 51008 1 (17) 260802 (10) 799300 CP113462 460990 (01) 0 0880304 51008 1 (17) 260416 (10) 460990 |
|---|
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-1114-2017%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.