FDA recall Z-2222-2025

Osteotec Limited · Class II · device

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 for recall

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

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status
Ongoing
Initiation date
2025-06-18
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Christchurch, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2025