Wright Medical Recalls CLAW II Orthopedic Plates Due to Material Error
Wright Medical Technology is recalling 1,127 CLAW II 2 Hole Plate Ortholoc 3DSi units 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 2/5 (Moderate).
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 1,127 units of the CLAW II 2 Hole Plate Ortholoc 3DSi, length 20mm, reference 40240220. These orthopedic plates are prescription-only and non-sterile. The recall is being conducted because the plates were manufactured from an incorrect raw material.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Canada, Australia, Great Britain, Germany, Spain, the Netherlands, and France. Specific lot numbers are listed in the agency's recall record.
Healthcare providers and patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 1,127
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: 1490004
- 1490005
- 1490199
- 1490200
- 1490201
- 1490202
- 1518483
- 1519493
- 1519494
- 1519495
- 1522021
- 1522898
- 1522899
- 1522900
- 1523735
- 1523736
- 1526519
- 1526520
- 1526521
- 1538760
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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