Ascension¿ Silicone PIP-Silicone PIP Sz 1 — Class II medical device recall Z-0691-2020
Terminated recall by Integra Lifesciences Sales Llc, reported 2019-12-25, distributed nationwide. Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained
| Recall number | Z-0691-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Lifesciences Sales Llc, Plainsboro, NJ, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2019-12-16 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 9 units |
| Reason classes | labeling |
| Lot numbers | 192715T |
| Model numbers | SPIP5201WW |
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 for recall
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0691-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.