Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects
Wright Medical Technology is recalling 102 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 medical device with a risk of intraoperative malfunction, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wright Medical Technology, Inc. is recalling 102 units of the CROSSCHECK(R) Plating system, specifically the LAPIDUS CX Plate, 1mm Step, Left (REF CCP-LPX1L). The product is intended for orthopedic use and was distributed nationwide.
The recall was initiated because the minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification. These dimensional deviations may result in intraoperative malfunction during surgical procedures.
Healthcare providers and facilities that have received these specific lot numbers (35049-31A-1, 35049-3A, 35049-3A-1-1, 362812, 36281-2-1) should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 102
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: 35049-31A-1
- 35049-3A
- 35049-3A-1-1
- 362812
- 36281-2-1
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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