Orthopedic Salvage System — Class II medical device recall Z-1114-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-02-08, distributed in CA, LA, MA, MD, NJ, TX, WA, WI. labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as
| Recall number | Z-1114-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-12-16 |
| Classified | 2017-01-28 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-07-21 |
| Distributed | CA, LA, MA, MD, NJ, TX, WA, WI |
| Quantity | 16 |
| Reason classes | labeling |
| Lot numbers | 003620, 0880304, 250928, 250929, 251007, 260324, 260416, 260417, 260622, 260714, 260802, 409190, 460990, 498380, 51008, 539760, 646200, 690040, 690050, 799300, CP113462 |
| Model numbers | 003620, 0880304, 250928, 250929, 251007, 260324, 260416, 260417, 260622, 260714, 260802, 409190, 460990, 498380, 51008, 539760, 646200, 690040, 690050, 799300, CP113462 |
Product
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Reason for recall
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.
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-1114-2017. 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.