FDA Recall
Terminated
Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
Recall: Z-2216-2010
·
Initiated April 6, 2010
Recall
- Recall Number
- Z-2216-2010
- Event Number
- 55364
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- LPH
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- April 6, 2010
- Posted
- August 12, 2010
- Terminated
- October 21, 2011
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
Reason
The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Action
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
Distribution
US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
Quantity
1,972 all products