Z-0691-2020 Class II Terminated
FDA device recall Z-0691-2020 was initiated by Integra Lifesciences Sales Llc on Nov 4, 2019 and is designated Class II. 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 The recall status is terminated (terminated May 5, 2020). Affected quantity: 9 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 25, 2019
- Initiation Date
- Nov 4, 2019
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product description
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 pattern
US Nationwide distribution in the state of CA.
Code information
Lot Number: Lot 192715T
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0691-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026