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Health product recall

Wright Medical Sterile Products (2016-11-09)

Starting date:
November 9, 2016
Posting date:
November 18, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61164

Affected Products

  1. Inbone Stem, Tibial, Top
  2. Valor Screw 5.0mm x 45mm Length

Reason

Wright Medical Technology is conducting a recall of certain sterile products due to a lack of adequate documentation confirming sterility. The affected sterile products are intended for use in the lower extremities. Implanting non-sterile products can lead to potential risks such as infection.

Affected products

A. Inbone Stem, Tibial, Top

Lot or serial number
  • 1540433
Model or catalog number
  • 200011901
Companies
Manufacturer

Wright Medical Technology Inc.

1023 Cherry Road

Memphis

38117

Tennessee

UNITED STATES



B. Valor Screw 5.0mm x 45mm Length

Lot or serial number
  • 1547961
Model or catalog number
  • 4151150045
Companies
Manufacturer

Wright Medical Technology Inc.

1023 Cherry Road

Memphis

38117

Tennessee

UNITED STATES