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