Recall Z-2222-2025— Osteotec Limited

Name: FDA recall Z-2222-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Class II · Ongoing

Class II FDA medical device recall by Osteotec Limited, initiated 2025-06-18. It names one FDA 510(k) clearance: K140453. 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. Reason: There is the potential that the silicone implant may contain foreign material.

Recalling firm: Osteotec Limited
Classification: Class II
Status: Ongoing
Initiated: 2025-06-18
Firm location: Christchurch, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K140453 — OSTEOTEC SILICONE FINGER IMPLANTOsteotec, Ltd.·cleared 2015-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.