This page has been archived on the Web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.
DELTA XTEND REVERSE SHOULDER SYSTEM -MODULAR CEMENTED and ECCENTRIC EPIPHYSIS (2017-09-13)
- Starting date:
- September 13, 2017
- Posting date:
- October 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64746
A. DELTA XTEND REVERSE SHOULDER SYSTEM -MODULAR CEMENTED EPIPHYSIS
B. DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS
Reason
DePuy Synthes is initiating a voluntary recall. For the recalled lots, an investigation determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. Further investigation, determined that the issue is related to the circularity of the cylinder. The circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) may not be able to be assembled.
Affected products
A. DELTA XTEND REVERSE SHOULDER SYSTEM -MODULAR CEMENTED EPIPHYSIS
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
130720101
130720201
Companies
- Manufacturer
-
Depuy France S.A.S.
7 ALLEE IRENE JOLIOT-CURIE, B.P. 256
SAINT PRIEST
69801
FRANCE
B. DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
130720102
130720103
130720202
130720203
Companies
- Manufacturer
-
Depuy France S.A.S.
7 ALLEE IRENE JOLIOT-CURIE, B.P. 256
SAINT PRIEST
69801
FRANCE