Agency classClass IIOur severity:High FDA (Devices)·Z-1482-2015·Announced 2015-04-29

Wright Medical Recalls Crosscheck Plating System Due to Spec Failures

Wright Medical Technology is recalling 51 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 51 units of the CROSSCHECK(R) Plating system, specifically the HOCKEY STICK CX Plate, Left (REF CCP-HSX1L), intended for orthopedic use. The affected units are identified by Lot Numbers 10345 and 35049-21A-1 and 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 facilities that have received these specific lots should stop using the affected devices and contact Wright Medical Technology for further instructions on the recall process.

The recalled product

Product: CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.
Manufacturer: Wright Medical Technology, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: intraoperative-malfunction
dimensional-defect
Affected units: 51

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 (2)

Lot Numbers: 10345
35049-21A-1

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