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PHEON MODULAR KNEE JOINTS (2015-07-24)
- Starting date:
- July 24, 2015
- Posting date:
- August 11, 2015
- 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-54588
Affected Products
- PHEON MODULAR KNEE JOINT 3R62
- PHEON MODULAR KNEE JOINT 3R62=1
Reason
Issue identified where locking function may fail if it is activated if the locking pin is not completely pulled out by patient; edge loading in locking surface causes a deformation of locking pin. The pin may get stuck in the guide of the upper section hindering the lock from engaging automatically in the extended position. The stability of the joint is then only by alignment and polycentric joint design and may result in buckling of the loaded joint.
Affected products
A. PHEON MODULAR KNEE JOINT 3R62
Lot or serial number
N/A
Model or catalog number
3R62
Companies
- Manufacturer
-
Otto Bock Healthcare GMBH
MAX NADER STRABE 15
DUDERSTADT
37115
GERMANY
B. PHEON MODULAR KNEE JOINT 3R62=1
Lot or serial number
N/A
Model or catalog number
3R62=1
Companies
- Manufacturer
-
Otto Bock Healthcare GMBH
MAX NADER STRABE 15
DUDERSTADT
37115
GERMANY