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Persona The Personalized Knee System Tibila Sizing Plate (2017-08-15)
- Starting date:
- August 15, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64548
Affected Products
- Persona The Personalized Knee System Tibila Sizing Plate
- Persona The Personalized Knee System Natural - Tibia Cemmented 5 Degree Stemmed Provisional
Reason
Potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Affected products
A. Persona The Personalized Knee System Tibila Sizing Plate
Lot or serial number
- 63531869
- 63531871
- 63576035
- 63649575
- 63693589
- 63576041
- 63688256
Model or catalog number
- 42-5399-083-01
- 42-5399-083-02
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
B. Persona The Personalized Knee System Natural - Tibia Cemmented 5 Degree Stemmed Provisional
Lot or serial number
- 63535352
- 63607357
- 63613121
- 63683139
Model or catalog number
- 42-5321-083-01
- 42-5321-083-02
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES