🔍 RecallPedia

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Class I - Dangerous
🏥 Medical Devices Recalled: May 3, 2016 Materialise USA Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot #154970
  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:
Materialise USA LLC
Reason for Recall:
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Product Codes/Lot Numbers:

Lot #154970

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1941-2016

Related Recalls

Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Materialise USA

Class I - Dangerous

The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.

Oct 16, 2014 Implants & Prosthetics Nationwide View Details →

REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

Materialise USA

Class I - Dangerous

Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

Nov 26, 2013 Implants & Prosthetics View Details →