Vanguard XP-XP & XP-XR Tibial Tray (2019-08-21)
- Starting date:
- August 21, 2019
- Posting date:
- August 30, 2019
- 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-70855
Last updated: 2019-09-05
Affected Products
- Vanguard XP-XP Tibial Tray
- Vanguard XP-CR Tibial Tray
Reason
Zimmer Biomet is conducting a medical device recall for the Vanguard XP-XP Tibial Tray due to the possibility of the locking bar not fully engaging. The issue was identified through a complaint investigation that determined that the edge of the tray may contain a burr that can prevent the locking bar from fully engaging. Burrs are not present on all trays and the surgical technique indicates that there should be user confirmation of proper engagement through visual (the locking bar arm, clasp, and polyethylene bearing must be flat on the baseplate in all directions) as well as auditory (clicks in place) checks. Based on complaint reports, when engagement was not initially fully achieved, the visual/audible check detected this condition intra-operatively. Following detection, use of the insertion tool and rigid instrumentation allowed for full engagement.
Affected products
A. Vanguard XP-XP Tibial Tray
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
B. Vanguard XP-CR Tibial Tray
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES