Osteotec Limited product recalled over foreign material

Recall date

June 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4…

Recall number

Z-2222-2025

FDA classification

Class II

Brand / firm

Osteotec Limited

Sold / distributed

US Nationwide distribution in the state of CA.

Why it was recalled

There is the potential that the silicone implant may contain foreign material

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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