Health product recall

POLYAXIAL SCREW (2020-12-22)

Starting date:
December 22, 2020
Posting date:
December 30, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74673



Last updated:
2020-12-30

Affected Products 

 

POLYAXIAL SCREW

Reason

A limited number of screws in a single lot (KRBX) of Yukon Polyaxial Screws- catalog number 7601-04026, size 4.0X26mm-were manufactured with 4.0X26mm dimensions and a dark blue shank, but incorrectly labeled (direct marked on screw) as catalog number 7601-05024, size 5.0X24mm. Therefore, these screws are longer and narrower than marked. Stryker has not received any reports of harm to patients associated with this nonconformance.

Affected products

POLYAXIAL SCREW

Lot or serial number
  • KRBX-302665
Model or catalog number

7601-04026

Companies
Manufacturer

K2M, Inc.

600 Hope Parkway SE

Leesburg

20175

Virginia

UNITED STATES