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Health product recall

DURACON TOTAL KNEE SYSTEM - HEMI,FLAT, TIBIAL AUGMENTS(2015-09-22)

Starting date:
September 22, 2015
Posting date:
October 8, 2015
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-55300

Affected Products

DURACON TOTAL KNEE SYSTEM - HEMI,FLAT, TIBIAL AUGMENTS

Reason

Stryker has received customer complaints regarding Duracon® Tibial Wedges implants puncturing the packaging's Tyvek lid(s).

Affected products

DURACON TOTAL KNEE SYSTEM - HEMI,FLAT, TIBIAL AUGMENTS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 6630-6-105
  • 6630-6-110
  • 6630-6-125
  • 6630-6-130
  • 6630-6-150
  • 6630-6-155
  • 6630-6-170
  • 6630-6-175
  • 6630-6-230
  • 6630-6-250
  • 6630-6-255
  • 6630-6-270
  • 6630-6-275
  • 6630-6-305
  • 6630-6-325
  • 6630-6-350
  • 6630-6-355
  • 6630-6-370
  • 6630-6-375
Companies
Manufacturer

Stryker Orthopeadics

325 Corporate Drive

Mahwah

New Jersey

UNITED STATES


Date modified: