CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems
FDA device recall Z-0062-2013 · posted 2012-10-15 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 59 both lots
- Distribution
- 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 B
- Date initiated
- 2012-09-13
- Date posted
- 2012-10-15
- Date terminated
- 2014-01-15
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLARLESS POLISHED TAPER HIP PROSTHESIS (K960658) | Zimmer, Inc. | 1996-07-16 |