Health product recall

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