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Health product recall

ADAPTOR AND LIGHT ADAPTOR FOR SMALL BATTERY DRIVE AND SMALL BATTERY DRIVE II (2016-06-28)

Starting date:
June 28, 2016
Posting date:
July 19, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59406

Affected products

A. ADAPTOR AND LIGHT ADAPTOR FOR SMALL BATTERY DRIVE AND SMALL BATTERY DRIVE II

Reason

DePuy Synthes has determined there is a potential for the adaptor and light adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the respective products to burst. Although preliminary internal tests for this failure mode have determined this scenario is highly unlikely to occur, DePuy Synthes has decided to recall the products.

Affected products

A. ADAPTOR AND LIGHT ADAPTOR FOR SMALL BATTERY DRIVE AND SMALL BATTERY DRIVE II

Lot or serial number

All lots

Model or catalog number
  • "05.001.024
  • 05.001.108"
Companies
Manufacturer

SYNTHES USA LLC

1302 WRIGHTS LANE EAST

WEST CHESTER

19380

UNITED STATES