Z-0691-2020 Class II Terminated
FDA device recall Z-0691-2020 was initiated by Integra Lifesciences Sales Llc on November 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
- December 25, 2019
- Initiation Date
- November 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