FDA Recall Terminated

Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.

Recall: Z-0091-06 · Initiated September 30, 2005

Recall

Recall Number
Z-0091-06
Event Number
33810
Firm
Zimmer Inc.
FEI Number
1000220733
Product Code
GFG
Status
Terminated
Root Cause
Other
Initiated
September 30, 2005
Posted
October 28, 2005
Terminated
December 28, 2005
Address
345 E Main St, Warsaw, IN, 46580-2746

Description

Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.

Reason

The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.

Action

Consignees were notified via recall letter dated 9/30/05.

Distribution

Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia.

Quantity

27