AERO-AL Revison Housing (2019-09-23)

Starting date:

September 23, 2019

Posting date:

November 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71595

Last updated: 2019-11-15

• 
  Reason
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  Affected products

Affected Products

AERO-AL Revison Housing

Reason

August 30, 2019, Stryker received reports of fractured AERO-AL Revision Housing detected during routine inspection by Stryker personnel. There are no reports of Revision Housing fractures occurring intraoperatively.

Stryker's investigation determined that the Revision Housing design is susceptible to fractures when exposed to stress resulting from deformation of the tray lids and brackets that hold the instruments during transport and storage.

Affected products