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Health product recall

Osteonics Self-Tapping Cancellous Bone Screws

Starting date:
August 21, 2012
Posting date:
September 17, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15541

Recalled Products

A. Osteonics Self-Tapping Cancellous Bone Screws

Reason

Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.

Affected products

A. Osteonics Self-Tapping Cancellous Bone Screws

Lot or serial number

MLH4L6, MLDXV2

Model or catalog number

2030-6535

Companies
Manufacturer
Howmedica Osteonics Corporation