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PROVIDE PROTECTION CAP (2015-10-02)
- Starting date:
- October 2, 2015
- Posting date:
- October 22, 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-55500
Affected Products
PROVIDE PROTECTION CAP
Reason
Through investigation, BIOMET 3i determined that the provided protection caps (PPC***) and the provided impression copings (PIC***) have not demonstrated adequate biocompatibility in that the items were both found to elicit a cytotoxic response (Grade 4).
Affected products
PROVIDE PROTECTION CAP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PPC484
PPC485
PPC654
PPC655
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES