Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Recalled by Osteotec Limited Due to Foreign Object Contamination

Date: June 18, 2025
Company: Osteotec Limited
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Osteotec Limited directly.

Affected Products

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

Quantity: 15573 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Osteotec Limited

Osteotec Limited has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report