Health product recall

Oxford Partial Knee System Fixed Lateral Tibial Construct, Right-Cemented, E3 (2020-12-02)

Starting date:
December 2, 2020
Posting date:
December 18, 2020
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-74567



Last updated:
2020-12-18

Affected Products

Oxford Partial Knee System Fixed Lateral Tibial Construct, Right-Cemented, E3

Reason

Zimmer Biomet is conducting a lot specific medical device recall for multiple sterile Zimmer Biomet products due to the potential for a breach in the sterile seal. A breach in the packaging seal could potentially lead to loss of sterility of the device. Based on an inspection of the affected packaging, a breach in the sterile seal is estimated to occur in less than 0.5% of the affected product.

Affected products

Oxford Partial Knee System Fixed Lateral Tibial Construct, Right-Cemented, E3

Lot or serial number

207230

Model or catalog number

154370

Companies
Manufacturer

BIOMET UK LIMITED ALSO TRADING AS BIOMET UK HEALTHCARE LTD

WATERTON INDUSTRIAL ESTATE

BRIDGEND

CF31 3XA

UNITED KINGDOM