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Segmental System,Polyethylene Inserts, B and C (2013-12-27)
- Starting date:
- December 27, 2013
- Posting date:
- January 17, 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-37601
Recalled products
- Segmental System, Polyethylene Insert, B
- Segmental System, Polyethylene Insert, C
Reason
Since launching the segmental system in 2007, Zimmer has received 13 complaints related to hyper-extension. This represents a complaint rate of approximately 0.4% since the product was introduced. Analysis of the explanted polyethylene insert also found that it typically exhibited anterior deformation in affected patients.
Affected products
A. Segmental System, Polyethylene Insert, B
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 00-5850-012-95
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES
B. Segmental System, Polyethylene Insert, C
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 00-5850-013-95
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES