Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4)
FDA device recall Z-2222-2025 · posted 2025-07-31 · Open, Classified
Recall details
- Recalling firm
- Osteotec Limited
- Reason for recall
- There is the potential that the silicone implant may contain foreign material
- Action taken
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KYJ
- Quantity affected
- 15573 units
- Distribution
- US Nationwide distribution in the state of CA.
- Date initiated
- 2025-06-18
- Date posted
- 2025-07-31
- Location
- Christchurch, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOTEC SILICONE FINGER IMPLANT (K140453) | Osteotec, Ltd. | 2015-04-17 |