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Health product recall

VARIOUS BIOMET ORTHOPEDIC PRODUCTS (2015-05-04)

Starting date:
May 4, 2015
Posting date:
August 18, 2015
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-54672

Affected Products

  1. BIOMET HIP SYSTEM, MODULAR HEAD COMPONENT-STANDARD
  2. BIOMET KNEE SYSTEM, MODULAR FINNED STEM
  3. MALLORY/HEAD PRIMARY HIP SYSTEM, LATERALIZED FEMORAL STEM
  4. BIOMET HIP SYSTEM, MODULAR HEAD COMPONENT-NO SKIRT
  5. COMPREHENSIVE SHOULDER SYSTEM, PRIMARY SHOULDER STEM

Reason

An internal non-conformance discovered by Biomet China reported that the GTIN codes on the outer labels of various Biomet orthopedics products are incorrect. There were 2 complaints describing the incorrect GTIN codes.

Affected products

A. BIOMET HIP SYSTEM, MODULAR HEAD COMPONENT-STANDARD

Lot or serial number

> 10 numbers, contact mfg.

Model or catalog number
  • 163667
  • 163668
  • 163669
  • 163670
Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES



B. BIOMET KNEE SYSTEM, MODULAR FINNED STEM

Lot or serial number

> 10 numbers, contact mfg.

Model or catalog number

141314

141316

141318

141320

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES



C. MALLORY/HEAD PRIMARY HIP SYSTEM, LATERALIZED FEMORAL STEM

Lot or serial number

127340

182030

349650

Model or catalog number

11-104211

11-104212

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES



D. BIOMET HIP SYSTEM, MODULAR HEAD COMPONENT-NO SKIRT

Lot or serial number

453220

Model or catalog number

163674

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES



E. COMPREHENSIVE SHOULDER SYSTEM, PRIMARY SHOULDER STEM

 

Lot or serial number

N/A

Model or catalog number

113644

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive

Warsaw

46581

Indiana

UNITED STATES


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