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