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Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz.
Recalled August 6, 2025 · FDA recall Z-2222-2025 · Osteotec
Hazard
There is the potential that the silicone implant may contain foreign material · FDA Class II
Units
15573 units
Sold at
US Nationwide distribution in the state of CA.
Description
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 anatomical variations and is supplied sterile. Component: N/A
Manufacturer(s)
Osteotec Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →