FDA Device recall Z-0691-2020
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cem…
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cem… by Integra Lifesciences Sales, citing silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0691-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-04 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences Sales |
| Distribution | US |
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.
Reason
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Identifiers
| code_info | Lot Number: Lot 192715T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0691-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.