The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2541-2015·Announced 2015-09-09

Wright Medical CrossCHECK Locking Screw Recall for Intraoperative Malfunction Risk

Wright Medical Technology is recalling 107 CrossCHECK Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing 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 is classified as FDA Class II, and the hazard involves a risk of intraoperative malfunction in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Wright Medical Technology, Inc. is recalling 107 units of CrossCHECK Locking Screws. The affected devices are distributed nationwide and are indicated for the stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hand, feet, wrist, ankles, fingers, and toes. The system is intended for single use in both pediatric and adult patients.

The recall is due to a potential for the screws to pass through the plate if torque is applied in excessive amounts. This defect may result in intraoperative malfunction. The source text does not report any specific illnesses, injuries, or fatalities associated with this recall.

Healthcare providers and patients should check their inventory and records for the specific reference numbers and lot numbers listed in the recall notice. If the device is in use, providers should contact Wright Medical Technology for instructions on how to proceed.

The recalled product

Product
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x…
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
107

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 (20)

  • REF CCP-L3010: Lot Number 35000
  • REF CCP-L3012: Lot Number 35000-6
  • 35000
  • REF CCP-L3014: Lot Number 35000-8
  • REF CCP-L3016: Lot Number 35000
  • REF CCP-L3018: Lot Number 35000
  • REF CCP-L3020: Lot Number 35000
  • REF CCP-L3022: Lot Numbers: 35000-16-1
  • REF CCP-L3024: Lot Number 35000
  • REF CCP-L3026: Lot Number 35000
  • REF CCP-L3028: Lot Number 35000
  • REF CCP-L3030: Lot Number 35000
  • REF CCP-L3032: Lot Number 35000
  • REF CCP-L3034: Lot Number 35000
  • REF CCP-L3036: Lot Number 35000
  • REF CCP-L3038: Lot Number 35000
  • REF CCP-L3040: Lot Number 35000
  • REF CCP-L3508: Lot Number 35004
  • REF CCP-L3510: Lot Numbers: 35004-3
  • 35004

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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