Osteotec Limited is recalling 15,573 units of its Silicone Finger Implants because the devices may contain foreign material within the silicone elastomer. The recall affects models OSTF-3, OSTF-4, and OSTF-5, which are one-piece sterile implants used during surgery to replace finger joints. While no injuries or incidents have been reported, the presence of contaminants in a surgical implant requires corrective action. These devices were distributed to hospitals and surgical centers, primarily in California.
The presence of foreign material in a finger implant could cause an adverse tissue reaction, inflammation, or infection once placed inside the body. No incidents or injuries have been reported to date.
One-piece, sterile, flexible silicone elastomer implant used in metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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