Health product recall

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

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

Hexapod Strut

Lot or serial number
  • Y14641
  • Y18430
Model or catalog number
  • 49350010
  • 49350030
Companies
Manufacturer
Stryker GMBH
Bohnackerweg 1,
Selzach, Solothurn
2545
SWITZERLAND