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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- 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.
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