Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 167 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 risk-of-harm product (orthopedic implant) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Wright Medical Technology, Inc. is recalling 167 units of the CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. This orthopedic device was distributed nationwide. The affected lot numbers are 3504917, 35049-17A, 35049-17A-1, 35049-18, 362791, and 36279-1-1.
The recall was initiated because the minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification. These dimensional defects may result in intraoperative malfunction during surgical procedures.
Healthcare providers and patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 167
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 (6)
- Lot Numbers: 3504917
- 35049-17A
- 35049-17A-1
- 35049-18
- 362791
- 36279-1-1
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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