Osteotec Limited: Device Recall
Recall #Z-2222-2025 · 06/18/2025
Recall Details
- Recall Number
- Z-2222-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Osteotec Limited
- Status
- Ongoing
- Date Initiated
- 06/18/2025
- Location
- Christchurch, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15573 units
Reason for Recall
There is the potential that the silicone implant may contain foreign material
Product Description
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
Distribution Pattern
US Nationwide distribution in the state of CA.