FDA Device Recall Z-0001-2007: GE OEC Medical Systems, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2007.

Recall Res Number

Z-0001-2007

Recalling Firm / Manufacturer

GE OEC Medical Systems, Inc

FEI Number

1720753

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-05-31

Date Posted

2006-10-03

Date Terminated

2011-07-27

Product Code

JAA

Event Number

35637

Product Quantity

143 units

Product Description GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)

Reason for Recall Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

Action Details Consignees were notified by letter on 05/31/2006

Distribution Pattern Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.

Code Information / Serial Numbers ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV

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Medical Device Recall: Z-0001-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer