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Health product recall

BIOMET Bone Screws (2016-04-06)

Starting date:
April 6, 2016
Posting date:
May 16, 2016
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-58344

Affected products 

  1. TITANIUM HEX HEAD SCREW BUTTRESS FULL THREAD
  2. EBI X FIX DYNAFIX SYSTEM HA COATED BONE SCREWS

Reason

Zimmer Biomet has initiated this action following an investigation which identified that specific lots produced may have an inadequate adhesive transfer from the Tyvek to the film. A weak seal may be evident.

Affected products

  1. TITANIUM HEX HEAD SCREW BUTTRESS FULL THREAD

Lot or serial number
  • 664820
Model or catalog number
  • 14-405032
Companies
Manufacturer
BIOMET TRAUMA
56 EAST BELL DRIVE P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES

B. EBI X FIX DYNAFIX SYSTEM HA COATED BONE SCREWS

Lot or serial number

16230

Model or catalog number

HAA60-13030

Companies
Manufacturer
BIOMET TRAUMA
56 EAST BELL DRIVE P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES

Date modified: