Health product recall

Ultra-Drive Irrigation Tubing Assembly and Hose/Drape Assembly (2019-06-13)

Starting date:
June 13, 2019
Posting date:
July 5, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70355



Last updated: 2019-07-05

Affected Products

  1. Ultra-Drive Irrigation Tubing Assembly
  2. Ultra-Drive Hose/Drape Assembly

Reason

Zimmer Biomet is conducting a medical device recall for the Ultra-Drive hose/drape assembly and Ultra-Drive irrigation tubing assembly due to insufficient data to support the labeled shelf life of 10 years.

Affected products

A. Ultra-Drive Irrigation Tubing Assembly

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

423834

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive, P.O. BOX 587

Warsaw

46581

Indiana

UNITED STATES


B. Ultra-Drive Hose/Drape Assembly

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

423833

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive, P.O. BOX 587

Warsaw

46581

Indiana

UNITED STATES