Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0558-2010

Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The...

Zimmer GmbH / initiated 2009-11-02 / Terminated / root cause: design

Zimmer Inc. began a recall of Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid... on . The reason FDA records is "The power cord female receptacle is not recessed sufficiently and may present a shock hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0558-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.
Product code
HAW Neurological Stereotaxic Instrument
Reason for recall
The power cord female receptacle is not recessed sufficiently and may present a shock hazard.
Root cause tag
design
FDA root cause
Device Design
Action
Zimmer sales staff were notified by letter dated 11/2/09 and instructed to locate the units and to upgrade the cords and to notify consignees by copy of a letter addressed to risk managers and dated 11/2/09.
Quantity in commerce
71
Distribution
Nationwide.
Product codes and lots
Workstation serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198.