PREBENT BURS (2015-12-28)

Starting date:

December 28, 2015

Posting date:

January 22, 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-56756

• Reason
• Affected products

Affected Products

PREBENT BURS

Reason

This recall has been initiated due to an assembly error caused by the inadvertent mixing of two sizes of bearings which occurred on the manufacturing line. ConMed received 10 complaints of metal shavings coming from the burs during use, due to contact between the bur and the hood of the Prebent Bur assembly. This could potentially render the device inoperable and could potentially cause a minor injury to the patient if the metal debris drops into the patient operative site. In no instance has it been reported to ConMed Corporation that this issue has resulted in illness or injury. All lots codes of catalog no. HPS-HB11, HPS-HB12 and HPS-HB13 (Hip Preservation System Signature Series Prebent Burs) manufactured from June 18, 2014, through to October 2, 2015, are being removed from the market by this recall action.

Affected products