The Recall Desk
SevereFDA (Devices)·Z-1492-2015·Announced 2015-04-29

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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.

See all 19 products in this recall →