The Recall Desk
HighFDA (Devices)·Z-2605-2014·Announced 2014-09-17

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

Wright Medical Technology is recalling 66 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic devices 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 is classified as FDA Class II, and the source text does not report any illnesses or injuries, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Wright Medical Technology, Inc. is recalling 66 units of CLAW II Straight Plate OrthoLoc 3DSi, Length 20mm x 20mm, REF 40242020. These orthopedic plates are prescription-only and non-sterile. The recall affects specific lot numbers: 1512153, 1518480, 1532497, 1538075, 1538076, and 1538332.

The reason for the recall is that the plates were manufactured from an incorrect raw material. The FDA has classified this as a Class II recall. 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 who have received these specific orthopedic plates should contact Wright Medical Technology or their local FDA office for further instructions on how to proceed with the recall.

The recalled product

Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Affected units
66

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 (6)

  • Lot Numbers: 1512153
  • 1518480
  • 1532497
  • 1538075
  • 1538076
  • 1538332

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 →