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Tornier Aequalis Reversed Impactors (2013-08-13)
- Starting date:
- August 13, 2013
- Posting date:
- December 17, 2013
- 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-37161
Recalled products
- Insert Impaction Handle
- Insert Impactor Tip
- Hemiprosthesis Adaptator Impactor Tip
- Anatomic Head Impactor Tip
Reason
Following the identification of the disassociation of an impactor tip during a surgery, or during the cleaning process. Tornier determined that a redeisign of the instrumentation was warranted.
Affected products
A. Insert Impaction Handle
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- MWD021
Companies
- Manufacturer
-
Tornier S.A.S.
161 Lavoisier Street
Montbonnot, Saint Martin
38330
FRANCE
B. Insert Impactor Tip
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- MWF023
Companies
- Manufacturer
-
Tornier S.A.S.
161 Lavoisier Street
Montbonnot, Saint Martin
38330
FRANCE
C. Hemiprosthesis Adaptator Impactor Tip
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- MWD024
Companies
- Manufacturer
-
Tornier S.A.S.
161 Lavoisier Street
Montbonnot, Saint Martin
38330
FRANCE
D. Anatomic Head Impactor Tip
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- MWD025
Companies
- Manufacturer
-
Tornier S.A.S.
161 Lavoisier Street
Montbonnot, Saint Martin
38330
FRANCE