Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 128 units of the Crosscheck Plating System because dimensional specifications are out of range, 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 medical device with a risk of intraoperative malfunction, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Wright Medical Technology, Inc. is recalling 128 units of the CROSSCHECK(R) Plating system, specifically the LAPIDUS CX Plate, NEUTRAL, Left (REF CCP-LPX0L). The product is intended for orthopedic use and was distributed nationwide. The affected lot numbers are 35049-1, 35049-1A-2, and 362811.
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 immediately and contact Wright Medical Technology for instructions on return or replacement. Patients who have already had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 128
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 (3)
- Lot Numbers: 35049-1
- 35049-1A-2
- 362811
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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