Recall Z-2222-2025 ยท KYJ Prosthesis, Finger, Constrained, Polymer
Osteotec Limited
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)
| Date | Jul 31, 2025 (initiated Jun 18, 2025) |
| Status | Open, Classified |
| Reason | There is the potential that the silicone implant may contain foreign material |
| Root cause | Process change control |
| Action | 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. Sh |
| Quantity | 15573 units |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140453 | OSTEOTEC SILICONE FINGER IMPLANT Osteotec, Ltd., Apr 17, 2015 |