Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant… — Class II medical device recall Z-2222-2025
Ongoing recall by Osteotec Limited, reported 2025-08-06, distributed nationwide. There is the potential that the silicone implant may contain foreign material
| Recall number | Z-2222-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osteotec Limited, Christchurch, United Kingdom |
| Recall initiated | 2025-06-18 |
| Classified | 2025-07-31 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 15,573 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 05060183090040, 05060183090057, 05060183090064 |
| Lot numbers | 127707, 127708, 127709, OSTF-3 |
| Model numbers | OSTF-3 |
| Expiration dates | 2028-07-17 |
Product
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A
Reason for recall
There is the potential that the silicone implant may contain foreign material
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-2222-2025. 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.