Wright Medical Recalls Crosscheck Plating System Due to Spec Deviations
Wright Medical Technology is recalling 270 units of the Crosscheck Plating System because specific dimensions are out of specification, 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Wright Medical Technology, Inc. is recalling 270 units of the CROSSCHECK(R) Plating system, specifically the MTP CX Plate, Left (REF CCP-MPX1L), intended for orthopedic use. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated because the minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification. These deviations may result in intraoperative malfunction during surgical procedures.
The affected units were distributed nationwide. The specific lot numbers involved are 3362771, 35049-13A, 35049-13A-1, 362771, 36277-1-2, and 3662771. Healthcare providers and facilities should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 270
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: 3362771
- 35049-13A
- 35049-13A-1
- 362771
- 36277-1-2
- 3662771
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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