Health product recall

REGENEREX PRIMARY TAPER (2020-09-11)

Starting date:
September 11, 2020
Posting date:
September 25, 2020
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-73997

Last updated:
2020-09-25

Affected Products

REGENEREX PRIMARY TAPER

Reason

Zimmer Biomet is conducting a lot specific medical device recall for the Regenerex Taper Cap, the Onpoint Scope Procedure Kit and the Arthrosimplicity Kit due to the items not properly being aligned with the adequate gamma sterilization group. This could result in the product not being properly sterilized. The syringe pump tubing sets in the kits are affected, but the entire kits listed in the affected must be returned. This issue was identified during the annual family review for sterile product.

Affected products

REGENEREX PRIMARY TAPER

Lot or serial number
  • 23900
  • 58930
  • 200720
  • 313260
  • 324440
  • 389060
  • 997610
Model or catalog number

141269

Companies
Manufacturer

Biomet Orthopedics

56 East Bell Drive, P.O. BOX 587

Warsaw

46581

Indiana

UNITED STATES