Device product
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Z-1567-2022
Product summary
- Event
- Event 90660
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17 devices
- Official record key
device-enforcement:Z-1567-2022
Official wording
Reason: An incorrect sizing label was applied to the carton packaging.
Code information: Lot numbers 1728375 and 1728376, UDI #00840420121707.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.
Derived failure modes
-
Unknown
An incorrect sizing label was applied to the carton packaging.