FDA Medical devices recall ·
Osteotec Product Name: Osteotec Silicone Finger Implant Model recall
- Recall number
- Z-2222-2025
- Date
- (initiated June 18, 2025)
- Company / brand
- Osteotec Limited
Unit 9, Christchurch, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15573 units
- Hazard tags
- Foreign material
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
There is the potential that the silicone implant may contain foreign material
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028, UDI-DI:5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028, UDI-DI:5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028, UDI-DI:5060183090064
Distribution
US Nationwide distribution in the state of CA.
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2222-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.