Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects
Wright Medical Technology is recalling 148 units of the Crosscheck Plating system because specific dimensions are out of specification, 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 is classified as FDA Class II, and the source text identifies a risk of intraoperative malfunction without reporting specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wright Medical Technology, Inc. is recalling 148 units of the CROSSCHECK(R) Plating system, specifically the LAPIDUS CX Plate, 2mm Step, Left (REF CCP-LPX2L). 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 defects may result in intraoperative malfunction during surgical procedures.
The affected lot numbers are 35049-9A, 35049-9A-1, 36281-1-11, 362841, and 36284-1-11. Healthcare providers and facilities should stop using these specific units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 148
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: 35049-9A
- 35049-9A-1
- 36281-1-11
- 362841
- 36284-1-11
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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