Device recall
Z-0691-2020: Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product…
FDA device recall · Class II · Integra Lifesciences Sales Llc
Key facts
| Recall number (Z-number) | Z-0691-2020 |
|---|---|
| Recall event | 84320 |
| Product | Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis. |
| Product code | KYJ |
| Recalling firm | Integra Lifesciences Sales Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2020 |
| 510(k) numbers | K082231 |
| FEI number | 3001700044 |
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