Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022
FDA device recall Z-1617-2009 · posted 2009-07-27 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.
- Action taken
- Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 147 of both products.
- Distribution
- Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.
- Date initiated
- 2009-05-29
- Date posted
- 2009-07-27
- Date terminated
- 2009-12-22
- 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 |
|---|---|---|
| ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY (K063251) | Zimmer, Inc. | 2007-01-24 |