Hexapod Strut (2018-08-17)

Starting date:

August 17, 2018

Posting date:

September 7, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67688

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  Reason
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  Affected products

Affected products

Hexapod Strut

Reason

Stryker GMBH identified a non-conformance with a supplier. The manufacturer has determined that products have left the factory where the press fit connection of the angular sleeve and pin of the u-joint and click lock did not meet specification. A dimensional discrepancy of the bore hole of the angular sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.

Affected products