Aequalis Ascend Flex - Humeral Stems (2019-11-11)
- Starting date:
- November 11, 2019
- Posting date:
- November 29, 2019
- 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-71758
Last updated: 2019-12-02
Affected Products
A. Aequalis Ascend Flex - Standard PTC Humeral Stem
B. Aequalis Ascend Flex - Long PTC Humeral Stem
C. Aequalis Ascend Flex - Standard Cemented Humeral Stem
D. Aequalis Ascend Flex - Long Cemented Humeral Stem
Reason
In rare instances, Aequalis Ascend Flex Humeral Stems may rub up against the blister packaging in which they sit causing some of that packaging material (PETG) to rub off onto the stems. This material is non-toxic and non-cytotoxic and the occurrence rate is very low (0.02%)
Affected products
A. Aequalis Ascend Flex - Standard PTC Humeral Stem
Lot or serial number
All codes.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot
FRANCE
B. Aequalis Ascend Flex - Long PTC Humeral Stem
Lot or serial number
All codes.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot
FRANCE
C. Aequalis Ascend Flex - Standard Cemented Humeral Stem
Lot or serial number
All codes.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot
FRANCE
D. Aequalis Ascend Flex - Long Cemented Humeral Stem
Lot or serial number
All codes.
Model or catalog number
More than 10 numbers, contact manufacturer. /
Companies
- Manufacturer
-
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot
FRANCE