FDA Device recall Z-1306-2018
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 by Zimmer Biomet, citing the drill guides were manufactured with the incorrect color anodization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1306-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-25 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | AZ, MO, MT, NJ, NY, OH, TX, WA |
Product
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Reason
The drill guides were manufactured with the incorrect color anodization.
Identifiers
| code_info | Package Lot: 989430; Lot Etched on Product: P0284 |
|---|
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-1306-2018%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.