Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Material
Wright Medical Technology is recalling 400 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 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 manufactured with an incorrect raw material, which presents a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Wright Medical Technology, Inc. is recalling 400 units of the CLAW II 2 Hole Plate Ortholoc 3DSi, length 25mm, reference 40240225. The recall is due to the plates being manufactured from an incorrect raw material. The affected products are non-sterile, prescription-only orthopedic devices.
The recall covers specific lot numbers: 1490367, 1490368, 1512152, 1521232, 1523734, 1523746, 1537160, 1537161, 1539401, 1541613, 1541614, 1542652, 1542774, and 1542775. These devices 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 check their inventory and patient records for these specific lot numbers. If the product is found, it should be removed from use and returned to Wright Medical Technology, Inc. according to the company's instructions.
The recalled product
- Product
- CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 400
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 (14)
- Lot Numbers: 1490367
- 1490368
- 1512152
- 1521232
- 1523734
- 1523746
- 1537160
- 1537161
- 1539401
- 1541613
- 1541614
- 1542652
- 1542774
- 1542775
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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