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Persona Articular Surface Inserter (2014-10-07)

Starting date:
October 7, 2014
Posting date:
October 22, 2014
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-41867

Recalled Products

Persona Articular Surface Inserter

Reason

Zimmer is initiating a lot specific recall of persona tibial articular surface inserters due to the potential for deformation of the tip. The instrument may not remain attached to the tibial baseplate during insertion of the articular surface. An investigation found that a group of 360 units did not undergo a heat treatment hardening step resulting in a lack in material strength that may contribute to deformation of the tip over time.

Affected products

Persona Articular Surface Inserter

Lot or serial number

56574291
56574317

Model or catalog number

42-5299-001-00

Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES