Product Wiki · Recalls · Health Canada — Medical Devices

Normed Foot and Ankle Instruments — recall 59442

Health Canada — Medical Devices · Canada · 2019-05-03 · Type II

As described by Health Canada — Medical Devices: Normed Foot and Ankle Instruments - Drill, Tap, Countersink (2019-04-04)

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Agency
Health Canada — Medical Devices
Recall identifier
59442
Date of alert
2019-05-03
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Zimmer GmbH is conducting a medical device recall for specific instruments formerly manufactured and marketed by Normed Medizin-Technik GmbH. All lots manufactured by this company are within the scope of this recall. Only instruments marked with the name/ logo "Normed" are subject to this removal action. Zimmer Biomet received complaints reporting tip breakages. An investigation identifies that Normed Medizin-Technik GmbH possibly manufactured certain lots from a different material than defined in the applicable specifications. As a precautionary measure Zimmer Biomet has decided to remove the complete family of instruments that were manufactured by Normed Medizin-Technik GmbH prior to its manufacturing transfer to Zimmer Biomet in 2014.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/normed-foot-and-ankle-instrume

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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