Device recall
Z-2222-2025: Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant…
FDA device recall · Class II · Osteotec Limited
Key facts
| Recall number (Z-number) | Z-2222-2025 |
|---|---|
| Recall event | 97126 |
| 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… |
| Product code | KYJ |
| Recalling firm | Osteotec Limited |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140453 |
| FEI number | 3008395366 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database