Device product
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Z-0583-2014
Product summary
- Event
- Event 66909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,024 units
- Official record key
device-enforcement:Z-0583-2014
Official wording
Reason: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Code information: Catalog number 1235-0-014 all lot codes
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.