Agency classClass IIOur severity:Severe FDA (Devices)·Z-1494-2015·Announced 2015-04-29

Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

Wright Medical Technology is recalling 233 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 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 agency classification is Class II, and the source text explicitly states the defect 'may result in intraoperative malfunction,' which constitutes a significant injury risk during a medical procedure.

Plain-English summary

Wright Medical Technology, Inc. is recalling 233 units of the CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. This orthopedic device was distributed nationwide. The specific lot numbers affected are 3504927, 35049-27A, 35049-27A-1, 35049-28, 362801, 36280-1-1, and 8752-010381.

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 and contact Wright Medical Technology for further instructions on the recall process.

The recalled product

Product: CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
Manufacturer: Wright Medical Technology, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: intraoperative-malfunction
manufacturing-defect
Affected units: 233

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: 3504927
35049-27A
35049-27A-1
35049-28
362801
36280-1-1
8752-010381

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.

See all 19 products in this recall →

Same manufacturer · Wright Medical Technology, Inc.

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Same hazard · intraoperative malfunction