Health product recall

OPUS SPEEDLOCK Knotless Fixation Device (2019-02-21)

Starting date:
February 21, 2019
Posting date:
March 8, 2019
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-69244

Affected Producrts

OPUS SPEEDLOCK Knotless Fixation Device

Reason

The devices are recalled (correction) due to an interference fit issue between the SPEEDLOCK Implant inserter and drill guides that could prevent the insertion of the SPEEDLOCK Implant through the drill guides.

Affected products

OPUS SPEEDLOCK Knotless Fixation Device

Lot or serial number
  • 1185957
  • 1185958
  • 2002717
  • 2009209
  • 2010033
  • 2010956
  • 2014729
Model or catalog number

OM-7500

Companies
Manufacturer

Arthrocare Corporation,

7000 W. William Cannon Drive,

Austin

78735

Texas

UNITED STATES