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Hintegra Tibial and Talar Implants and Revision Components (2014-02-25)
- Starting date:
- February 25, 2014
- Posting date:
- April 4, 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-38769
Recalled Products
A. Hintegra Tibial Implant
B. Hintegra Talar Implant with Pegs
C. Hintegra Revision Talar Component
D. Hintegra Revision Tibial Component
Reason
A risk of damage to the package (external pouch) of the Hintegra Total Ankle prosthesis tibial and talar components during shipping/handling. This damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection.
Affected products
A. Hintegra Tibial Implant
Lot or serial number
All lots
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Newdeal Sas
Immeuble Sequoia 2
B. Hintegra Talar Implant with Pegs
Lot or serial number
All lots
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Newdeal Sas
Immeuble Sequoia 2
C. Hintegra Revision Talar Component
Lot or serial number
All lots
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Newdeal Sas
Immeuble Sequoia 2
D. Hintegra Revision Tibial Component
Lot or serial number
All lots
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Newdeal Sas
Immeuble Sequoia 2