This page has been archived on the Web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.
Attune Fixed Bearing Tibial and Femoral Component Impactor, Attune Rotating Platform Tibial Impact, and Attune Intuition Impaction Handle (2014-11-11)
- Starting date:
- November 11, 2014
- Posting date:
- November 21, 2014
- 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-42249
Recalled products
- Attune Fixed Bearing Tibial Impactor
- Attune Femoral Component Impactor
- Attune Rotating Platform Tibial Impact.
- Attune Intuition Impaction Handle
Reason
Depuy is issuing a customer letter to notify users that all lots of attune intuition impaction handle and impactors have the potential to fracture during impaction. If not observed during surgery, broken pieces of the instruments may be left in the patient.
Affected products
A. Attune Fixed Bearing Tibial Impactor
Lot or serial number
All lots
Model or catalog number
- 254401003
Companies
- Manufacturer
-
Depuy (Ireland)
Loughbeg
Ringaskiddy
IRELAND
B. Attune Femoral Component Impactor
Lot or serial number
All lots
Model or catalog number
- 254401006
Companies
- Manufacturer
-
Depuy (Ireland)
Loughbeg
Ringaskiddy
IRELAND
C. Attune Rotating Platform Tibial Impact
Lot or serial number
All lots
Model or catalog number
- 254401004
Companies
- Manufacturer
-
Depuy (Ireland)
Loughbeg
Ringaskiddy
IRELAND
D. Attune Intuition Impaction Handle
Lot or serial number
All lots
Model or catalog number
- 254401017
Companies
- Manufacturer
-
Depuy (Ireland)
Loughbeg
Ringaskiddy
IRELAND