Class II — Osteotec Limited
| Recalling firm | Osteotec Limited |
|---|---|
| Registered facility | OSTEOTEC LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is the potential that the silicone implant may contain foreign material |
| 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… |
| Quantity | 15573 units |
| Distribution | US Nationwide distribution in the state of CA. |
| Initiated | 2025-06-18 |
| Classified | 2025-07-31 |
| Recall number | Z-2222-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Osteotec Limited (Z-2222-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97126/
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