The Recall Desk
ModerateFDA (Devices)·Z-2087-2013·Announced 2013-09-04

Synthes 2.4 mm VA-LCP Distal Radius Plate Recall for Mislabeling

Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (mis-etching) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Synthes USA HQ, Inc. is recalling 11 units of the Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right. The recall involves Part No. 02.111.730 with Lot No. 3614792. These medical devices are intended for the fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

The recall was initiated because there is a possibility that the plates from this specific lot are etched with "R" for right when they should be etched with "L" for left. This labeling error could result in the implantation of a plate intended for the wrong side of the body.

The affected units were distributed nationwide in the United States, specifically in the states of Florida, Georgia, North Carolina, Ohio, Kentucky, New Jersey, Idaho, Indiana, and Minnesota. Healthcare providers and patients should verify the lot number and side designation of any implanted or pending implants to ensure they match the intended surgical site.

The recalled product

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.
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part No. 02.111.730
  • with Lot No. 3614792

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically: