FDA Enforcement
Class II
Terminated
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.
Recall: Z-0691-2020
·
Reported December 25, 2019
Enforcement
- Recall Number
- Z-0691-2020
- Event ID
- 84320
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra Lifesciences Sales Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 25, 2019
- Initiation Date
- November 4, 2019
- Classification Date
- December 16, 2019
- Termination Date
- May 5, 2020
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States
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
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Code Info
Lot Number: Lot 192715T
Distribution
US Nationwide distribution in the state of CA.
Quantity
9 units