# FDA recall Z-0691-2020

> **Integra Lifesciences Sales Llc** · Class II · device recall initiated 2019-11-04.

## 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

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-0691-2020
- **Recalling firm:** Integra Lifesciences Sales Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-04
- **Report date:** 2019-12-25
- **Termination date:** 2020-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0691-2020

## Citation

> AI Analytics. FDA recall Z-0691-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0691-2020. Source: US FDA. Licensed CC0.

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