Zimmer Segmental System — Class II medical device recall Z-0721-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-07, distributed nationwide. The products being recalled exceeded the weight previously tested leading to a possibility of damage to the pa
| Recall number | Z-0721-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-08-01 |
| Classified | 2018-02-26 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, BS, CA, CH, CN, DE, DO, ES, FR, GB, IL, JP, KR, LB, MX, MY, NL, PA, SG, TH |
| Quantity | 3,350 units |
| Reason classes | sterility |
| Model numbers | 00585001201, 00585001202, 00585001301, 00585001302 |
Product
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
Reason for recall
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
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-0721-2018. 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.