The Recall Desk
HighFDA (Devices)·Z-2607-2014·Announced 2014-09-17

Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Plates

Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a manufacturing defect (incorrect raw material) which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Wright Medical Technology, Inc. is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi, length 25mm x 25mm, REF 40242525. These orthopedic plates are prescription-only and non-sterile. The recall involves specific lot numbers: 1517327, 1538333, and 1543490.

The reason for the recall is that the plates were manufactured from an incorrect raw material. The affected units were distributed nationwide in the United States and internationally to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France.

Healthcare providers and patients should stop using these specific orthopedic plates and contact Wright Medical Technology for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Affected units
18

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 (3)

  • Lot Numbers: 1517327
  • 1538333
  • 1543490

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Wright Medical Technology, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →