Z-0407-2014 Class II Terminated
FDA device recall Z-0407-2014 was initiated by Synthes USA HQ, Inc. on Jul 30, 2013 and is designated Class II. Reason for recall: The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. The recall status is terminated (terminated Sep 10, 2015). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 30, 2013
- Termination Date
- Sep 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Reason for Recall
The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
Code Information
Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517