Device product
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Z-0394-2014
Product summary
- Event
- Event 66580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3087
- Official record key
device-enforcement:Z-0394-2014
Official wording
Reason: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
Code information: part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Labeling or packaging
mislabeled