CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Recall
- Recall Number
- Z-0060-2013
- Event Number
- 63124
- Firm
- Zimmer, Inc.
- FEI Number
- 1000220733
- Status
- Terminated
- Root Cause
- Packaging change control
- Initiated
- September 13, 2012
- Posted
- October 15, 2012
- Terminated
- January 15, 2014
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.
Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.
Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
59 both units