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Recall Observatory FDA recall evidence

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

July 30, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
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

    reason.no_named_rule · v1.0.0

    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.