Wright Medical Crosscheck Plating System Recalled for Dimensional Defects
Wright Medical Technology is recalling 138 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 involves a risk-of-harm product (medical device) where intraoperative malfunction is possible, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Wright Medical Technology, Inc. is recalling 138 units of the CROSSCHECK(R) Plating system, Utility Plate, 5-Hole (REF CCP-UTN5), intended for orthopedic use. The affected units were 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 patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices. The specific lot numbers associated with this recall are 3504933, 35049-33A, 35049-33A-1, 35049-34, 362804, and 36280-4-1-A.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 138
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 (6)
- Lot Numbers: 3504933
- 35049-33A
- 35049-33A-1
- 35049-34
- 362804
- 36280-4-1-A
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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