🔍 RecallPedia

The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths

Class I - Dangerous
🏥 Medical Devices Recalled: February 9, 2022 Wright Medical Technology Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model No. DCS2825126; Lot No. 11012187061566009
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Wright Medical Technology, Inc.
Reason for Recall:
Product was labelled with the incorrect manufacturing and distribution dates.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths

Product Codes/Lot Numbers:

Model No. DCS2825126; Lot No. 11012187061566009

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0679-2022

Related Recalls

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Wright Medical Technology

Class I - Dangerous

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

Mar 6, 2024 Other Medical Devices View Details →