Device 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.
Z-0691-2020
Product summary
- Event
- Event 84320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-0691-2020
Official wording
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 information: Lot Number: Lot 192715T
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Labeling or packaging
mislabeled