Health product recall

Proximal Humerus Plate Template 90, 140, 234 mm & Cannulated Screw Tap 6.5, 8.0 mm (2020-05-22)

Starting date:
May 22, 2020
Posting date:
June 5, 2020
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-73257

Last updated: 2020-06-05

Affected Products

A. Proximal Humerus Plate Template 90, 140, 234 mm
B. Cannulated Screw Tap 6.5, 8.0 mm

Reason

Zimmer Biomet is conducting a lot specific medical device recall for the A.L.P.S. proximal humerus, and the 6.5/8.0mm biomet cannulated screw system. The affected devices did not have complete design history files and design transfer files prior to distribution.

Affected products

A. Proximal Humerus Plate Template 90, 140, 234 mm

Lot or serial number
  • 429698
  • 451853
  • 452448
  • 462794
  • 624820
Model or catalog number
  • 110025471
  • 110025472
  • 110025473
Companies
Manufacturer
BIOMET TRAUMA
56 EAST BELL DRIVE P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES

B. Cannulated Screw Tap 6.5, 8.0 mm

Lot or serial number
  • 429698
  • 624820
  • 624830
  • 867200
  • 867210
Model or catalog number
  • 110008466
  • 110008467
Companies
Manufacturer
BIOMET TRAUMA
56 EAST BELL DRIVE P.O. BOX 587
WARSAW
46581
Indiana
UNITED STATES