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Health product recall

NORIAN DRILLABLE, CALCIUM PHOSPHATE BONE VOID FILLER (2016-05-10)

Starting date:
May 10, 2016
Posting date:
May 24, 2016
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-58512

Affected products 

  1. NORIAN DRILLABLE, CALCIUM PHOSPHATE BONE VOID FILLER

Reason

The rotary pouch within the affected parts and lot numbers may potentially be labelled with the incorrect powder volume/size, however, the rotary pouch contains the correct powder volume/size according to the outer box label.

Affected products

A. NORIAN DRILLABLE, CALCIUM PHOSPHATE BONE VOID FILLER

Lot or serial number

More than 10 numbers, contact manufacturer.   

Model or catalog number

07.704.003S
07.704.005S
07.704.010S

Companies
Manufacturer
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES