Device product
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.
Z-0060-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 63124
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 both units
- Official record key
device-enforcement:Z-0060-2013
Official wording
Reason: 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.
Code information: Lot 61947708
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
packaging issue