Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 372 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 is classified as FDA Class II and involves a risk of intraoperative malfunction, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Wright Medical Technology, Inc. is recalling 372 units of the CROSSCHECK(R) Plating system, Utility Plate, 4-Hole (REF CCP-UTN4). This orthopedic device was distributed nationwide. The affected lot numbers are 3504931, 35049-31A, 35049-31A-1, 35049-32, 362803, 36280-3-1, and 8752-010381.
The recall was initiated because the minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification. The source text states that these defects may result in intraoperative malfunction.
Healthcare providers and facilities that have received these devices should stop using them and contact Wright Medical Technology for instructions on return or replacement. Patients who have had these devices implanted should consult their healthcare provider for guidance.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 372
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 (7)
- Lot Numbers: 3504931
- 35049-31A
- 35049-31A-1
- 35049-32
- 362803
- 36280-3-1
- 8752-010381
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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