Device product
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.
Z-2087-2013
Product summary
- Event
- Event 65890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-2087-2013
Official wording
Reason: 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.
Code information: Part No. 02.111.730, with Lot No. 3614792
Distribution pattern: USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Derived failure modes
-
Unknown
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.