Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 100 units of Crosscheck Plating Systems because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a structural defect in a medical device that may result in intraoperative malfunction, which aligns with the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
Wright Medical Technology, Inc. is recalling 100 units of the CROSSCHECK(R) Plating system, Utility Plate, 6-Hole (REF CCP-UTN6). The product is intended for orthopedic use and was distributed nationwide. The specific lot numbers involved are 3504935, 35049-35, 35049-35A, and 35049-35A-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, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 100
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 (4)
- Lot Numbers: 3504935
- 35049-35
- 35049-35A
- 35049-35A-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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