Osteotec Silicone Finger Implant (Osteotec) – Foreign Material (2025)
A potential foreign material in a silicone implant may require medical monitoring.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 stabi
Brand
Osteotec Limited
Lot Codes / Batch Numbers
Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028, UDI-DI:5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028, UDI-DI:5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028, UDI-DI:5060183090064
Products Sold
Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028, UDI-DI:5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028, UDI-DI:5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028, UDI-DI:5060183090064
Osteotec Limited is recalling Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz due to There is the potential that the silicone implant may contain foreign material. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential that the silicone implant may contain foreign material
Recommended Action
Per FDA guidance
On June 18, 2025, Osteotec issued an Urgent Medical Device Recall Notification via E-Mail. Osteotec asked consignees to take the following actions: 1. Immediately review your inventory and quarantine any of the affected LOTs. 2. If a physician has successfully implanted the device, they physician should continue to monitor the implant for any infections or issues. If a physician has successfully implanted a device that potentially could contain foreign material, it is recommended that they continue to monitor the patient for any infections or issues associated with the recalled device. 3. Share this Product Recall letter within your facility network and forward to any customers to whom you have distributed products from the affected LOTs to ensure awareness. 4. Complete and return the attached response and acknowledgement form to Osteotec. 5. Return affected products to your Agent/Distributor/Osteotec
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026