Zimmer — Class II medical device recall Z-0625-2016
Terminated recall by Zimmer Biomet, Inc., reported 2016-01-20, distributed in AL, AZ, CA, CO, FL, GA, ID, MI…. Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing t
| Recall number | Z-0625-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-11-17 |
| Classified | 2016-01-09 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-08-12 |
| Distributed | AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NJ, NV, OK, OR, PA, SD, TN, TX, WA, WI |
| Countries outside the US | AU, CH, DE, SE |
| Quantity | 372 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00889024328952 |
| Lot numbers | 62536230, 62745662, 62758613, 62773482, 62874869, 62947660, 62968065 |
| Model numbers | 07.01738.001 |
Product
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Reason for recall
Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
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-0625-2016. 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.