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DRIVERS AND DRIVER TIPS (2015-08-10)
- Starting date:
- August 10, 2015
- Posting date:
- September 1, 2015
- 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-54862
Affected Products
- DRIVERS AND DRIVER TIPS
Reason
The production documentation for the impacted items was inadvertently swapped during manufacturing. This caused the packaging labels to be created and applied incorrectly. Additionally, because of the swap, the RASQ3N received the RASH3N's laser marking "RASH3N" along the body of the driver tip.
Affected products
A. DRIVERS AND DRIVER TIPS
Lot or serial number
- 1184554
- 1184555
Model or catalog number
- RASH3N
- RASQ3N
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES