Health product recall

Cobalt Chrome Modular Head Component and 36mm Modular Head (2018-04-11)

Starting date:
April 11, 2018
Posting date:
May 1, 2018
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-66612

Affected products

A. COBALT CHROME MODULAR HEAD COMPONENT

B. 36MM MODULAR HEAD

Reason

Zimmer Biomet is conducting a medical device recall for two lots of Modular Head Components due to a complaint indicating that a 36mm head was in box labeled as 32mm. The investigation determined that the two affected lots were potentially commingled and therefore are being recalled.

Affected products

A. COBALT CHROME MODULAR HEAD COMPONENT

Lot or serial number

276760

Model or catalog number

163669

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

UNITED STATES


B. 36MM MODULAR HEAD

Lot or serial number

299340

Model or catalog number

11-363661

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

UNITED STATES