Product Wiki · Recalls · Health Canada — Medical Devices

Variax Screw — recall 44458

Health Canada — Medical Devices · Canada · 2017-05-16 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 44458
Date of alert: 2017-05-16
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: Stryker internally identified that the select batch of the Variax Bone Screws had been manufactured with the incorrect raw material. Screws should be grade 5 titanium [T005] but were made with grade 4 titanium [T014]. No hazards were identified. Both materials are used for Stryker Osteosynthesis implant screws and both materials have very good biocompatible characteristics. The substitution for T014 / T005 for the screws does not represent a significant incremental medical risk to the patient.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/variax-screw

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Variax Screw — recall 44458

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