The Recall Desk
HighFDA (Devices)·Z-2542-2015·Announced 2015-09-09

Wright Medical Recalls CrossCHECK Non-Locking Screws Due to Malfunction Risk

Wright Medical Technology is recalling 5,687 CrossCHECK Non-Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.

What this means for you

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. The hazard involves a risk of intraoperative malfunction, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria.

Plain-English summary

Wright Medical Technology, Inc. is recalling 5,687 units of CrossCHECK Non-Locking Screws. The affected devices are available in various sizes, including 3.0 mm and 3.5 mm diameters with lengths ranging from 8 mm to 40 mm. The recall covers specific lot numbers, primarily from the 34995 and 34996 series, as well as lots 0114 and 1213.

The recall was initiated because the screws have a potential to pass through the plate if torque is applied in excessive amounts. This defect may result in intraoperative malfunction during surgical procedures. The CrossCHECK Plating System is 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 device is intended for single use and may be used in both pediatric and adult patients.

The affected units were distributed nationwide. Healthcare providers and patients should check their inventory or medical records for the specific reference numbers and lot numbers listed in the recall notice. If the device is currently in use, providers should contact Wright Medical Technology for instructions on how to proceed.

The recalled product

Product
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
5,687

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)

  • 34996-2
  • 34996-2-1
  • 34996
  • REF CCP-N3010: Lot Numbers: 34996-3
  • 34996-4
  • 34996-4-1
  • REF CCP-N3012: Lot Numbers: 34996-5
  • 34996-6
  • 34996-6-1
  • REF CCP-N3014: Lot Numbers: 10157-01
  • 34996-7
  • 34996-8
  • 34996-8-1
  • REF CCP-N3016: Lot Numbers: 34996-10
  • 34996-10-1
  • 34996-9
  • REF CCP-N3018: Lot Numbers: 34996-11
  • 34996-12
  • 34996-12-1
  • REF CCP-N3020: Lot Numbers: 34996-13

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 →

Related recalls

Same manufacturer · Wright Medical Technology, Inc.

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Same hazard · intraoperative malfunction

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