This page has been archived on the Web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.
E-Pen - Burr Attachment
- Starting date:
- May 10, 2013
- Posting date:
- June 17, 2013
- 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-34189
Recalled products
- E-Pen - Burr Attachment
Reason
Synthes (Canada), Ltd. received notification from its supplier, Synthes GmbH, that a medical device recall was being initiated for part number (05.001.046), lot number (8230998) due to incorrect labelling of the device. This voluntary recall of the Burr attachment, "M" is used with Synthes Electric Pen Drive and Air Pen Drive systems. One delivery of Burr attachment "l" were marked with the marking of an "M", and that Burr attachment M were marked with the marking of an "l".
Affected products
A. E-Pen - Burr Attachment
Lot or serial number
- 8230998
Model or catalog number
- 05.001.046
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA