A — Class II medical device recall Z-1306-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-04-11, distributed in AZ, MO, MT, NJ, NY, OH, TX, WA. The drill guides were manufactured with the incorrect color anodization.
| Recall number | Z-1306-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-10-25 |
| Classified | 2018-04-03 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2020-05-01 |
| Distributed | AZ, MO, MT, NJ, NY, OH, TX, WA |
| Countries outside the US | CL, NL |
| Quantity | 22 |
| Lot numbers | 989430 |
| Model numbers | 816209003 |
Product
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Reason for recall
The drill guides were manufactured with the incorrect color anodization.
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-1306-2018. 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.