Health product recall

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

  1. Vanguard XP-XP Tibial Tray
  2. 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