Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 151 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
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 involves a high-risk medical device with a defect that may result in intraoperative malfunction, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Wright Medical Technology, Inc. is recalling 151 units of the CROSSCHECK(R) Plating system, Utility Plate, 7-Hole (REF CCP-UTN7), intended for orthopedic use. The recall is due to the minor diameter, major diameter, thread pitch, and pitch on the Crosscheck being out of specification.
The defect may result in intraoperative malfunction. The affected units were distributed nationwide. The specific lot numbers involved are 3504937, 35049-37A, 35049-37A-1, 35049-38, and 362806.
Healthcare providers and facilities should stop using the affected units and contact Wright Medical Technology for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 151
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 (5)
- Lot Numbers: 3504937
- 35049-37A
- 35049-37A-1
- 35049-38
- 362806
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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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