This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Osteoraptor Sutures (2017-02-10)
- Starting date:
- February 10, 2017
- Posting date:
- February 28, 2017
- 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-62414
Affected Products
A. Osteoraptor 2.9 Suture Anchor w/ Two Ultrabraid Sutures
B. Osteoraptor 2.3 Suture Anchor w/ One Ultrabraid Suture
Reason
Smith & Nephew, Inc. is initiating a voluntary field corrective action/recall of all batches (shipped from September 2013 through October 2016) of the Osteoraptor with Ultrabraid Suture due to a labelling error. The outer box incorrectly states the suture colour as blue, the provided suture is white. The inner label is correct.
Affected products
A. Osteoraptor 2.9 Suture Anchor w/ Two Ultrabraid Sutures
Lot or serial number
50483677
Model or catalog number
72202165
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
B. Osteoraptor 2.3 Suture Anchor w/ One Ultrabraid Suture
Lot or serial number
50474895
50487785
Model or catalog number
72201991
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES