FDAClass IIApril 29, 2015

CROSSCHECK(R) Plating system recall

CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.

Why was CROSSCHECK(R) Plating system recalled?

The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 35049-31A-1, 35049-3A, 35049-3A-1-1, 362812, 36281-2-1

Product
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
Recalling firm
Wright Medical Technology, Inc.
Quantity
102 units
Distribution
Nationwide Distribution.
Recall date
April 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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