Device product
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Z-0870-2016
Product summary
- Event
- Event 73156
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147,838 units in total
- Official record key
device-enforcement:Z-0870-2016
Official wording
Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Code information: Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.