Wright Medical Recalls CLAW II 2 Hole Plate OrthoLoc 3DSi Orthopedic Plates
Wright Medical Technology is recalling 497 CLAW II 2 Hole 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 is classified as FDA Class II, and the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High.
Plain-English summary
Wright Medical Technology, Inc. is recalling 497 units of the CLAW II 2 Hole Plate OrthoLoc 3DSi, length 15mm, reference 40240215. These orthopedic plates are prescription-only and non-sterile. The recall was initiated because the plates were manufactured from an incorrect raw material.
The affected products were distributed nationwide in the United States and internationally to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France. The recall includes specific lot numbers: 1487673, 1487674, 1487675, 1487676, 1490003, 1512150, 1512151, 1519497, 1519498, 1522019, 1522020, 1523747, 1523748, 1537072, 1537073, 1537162, 1539399, 1541615, 1541616, 1543148, and 1543149.
Healthcare providers and patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 497
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 (20)
- Lot Numbers: 1487673
- 1487674
- 1487675
- 1487676
- 1490003
- 1512150
- 1512151
- 1519497
- 1519498
- 1522019
- 1522020
- 1523747
- 1523748
- 1537072
- 1537073
- 1537162
- 1539399
- 1541615
- 1541616
- 1543148
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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