Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects
Wright Medical Technology is recalling 308 units of the Crosscheck Plating System 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 3/5 (High).
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 hospitalizations, 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 308 units of the CROSSCHECK(R) Plating system, Utility Plate, 3-Hole (REF CCP-UTN3). 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 should stop using the affected devices and contact the manufacturer for further instructions. The affected lot numbers are 3504929, 35049-29A, 35049-29A-1, 35049-30, 362802, 36280-2-2, and 8752-010391.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 308
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: 3504929
- 35049-29A
- 35049-29A-1
- 35049-30
- 362802
- 36280-2-2
- 8752-010391
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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