Z-0394-2014 Class II Terminated
FDA device recall Z-0394-2014 was initiated by Synthes USA HQ, Inc. on Oct 3, 2013 and is designated Class II. Reason for recall: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. The recall status is terminated (terminated Dec 18, 2015). Affected quantity: 3087.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Oct 3, 2013
- Termination Date
- Dec 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3087
Product Description
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.
Reason for Recall
During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
Distribution Pattern
Nationwide Distribution
Code Information
part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841