Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 233 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the source text explicitly states the defect 'may result in intraoperative malfunction,' which constitutes a significant injury risk during a medical procedure.
Plain-English summary
Wright Medical Technology, Inc. is recalling 233 units of the CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. This orthopedic device was distributed nationwide. The specific lot numbers affected are 3504927, 35049-27A, 35049-27A-1, 35049-28, 362801, 36280-1-1, and 8752-010381.
The recall was initiated because the minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification. These dimensional deviations may result in intraoperative malfunction during surgical procedures.
Healthcare providers and facilities that have received these specific units should stop using them and contact Wright Medical Technology for further instructions on the recall process.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 233
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: 3504927
- 35049-27A
- 35049-27A-1
- 35049-28
- 362801
- 36280-1-1
- 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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