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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