Wright Medical Recalls Crosscheck Plating System Due to Specification Defects
Wright Medical Technology is recalling 92 units of the Crosscheck Plating system because dimensional specifications are out of range, posing a risk of intraoperative malfunction.
What this means for you
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 constitutes 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 92 units of the CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1, 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 defects may result in intraoperative malfunction during surgical procedures.
The specific lot numbers involved are 35049-25A, 35049-25A-1, and 36286-1-2. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices immediately.
The recalled product
- Product
- CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 92
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: 35049-25A
- 35049-25A-1
- 36286-1-2
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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