Reported Aug 6, 2025 · Ongoing
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz.…
Osteotec Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Osteotec Limited · Unit 9 · Christchurch · N/A
Is this the product you have?
- Brand NameOsteotec
- Product NameOsteotec Silicone
- Finger Implant Model/Catalog Number
OSTF-3 (Sz. 3)OSTF-4 (Sz. 4)OSTF-5 (Sz. 5)
- Software VersionN/A
- Product DescriptionThe 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
- ComponentN/A
- Lot codes and dates
- Lot CodeOSTF-3 LOT 127707 Exp 07/17/2028
- UDI-DI5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028
- UDI-DI5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028
- UDI-DI5060183090064
- Amount recalled
- 15573 units
Where it was sold
- Nationwide
- CA
Why it was recalled
There is the potential that the silicone implant may contain foreign material
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new foreign material recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.