Z-2087-2013 Class II Terminated
FDA device recall Z-2087-2013 was initiated by Synthes USA HQ, Inc. on Jul 30, 2013 and is designated Class II. Reason for recall: The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate. The recall status is terminated (terminated May 21, 2015). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 4, 2013
- Initiation Date
- Jul 30, 2013
- Termination Date
- May 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
Reason for Recall
The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
Distribution Pattern
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Code Information
Part No. 02.111.730, with Lot No. 3614792