ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revi
FDA device recall Z-0324-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.
- Action taken
- The firm Zimmer, sent an "URGENT DEVICE CORRECTION" letter dated August 26, 2011 to Marketing Personnel, Distributors, Sales Representatives, Distribution Operation Managers, and Surgeons. The letters identified the reason for the recall, the product, and required actions to be taken. The letter also included Medwatch reporting information and a Certificate of Acknowledgement form to fax back to the recalling firm to confirm receipt of the recall notice. For questions contact Zimmer at 1-877-946-2761.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 119,284 total devices
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschba
- Date initiated
- 2011-10-21
- Date posted
- 2011-12-01
- Date terminated
- 2013-08-29
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 (K031572) | Zimmer, Inc. | 2003-06-24 |
| ZMR HIP SYSTEM-POROUS REVISION (K994286) | Zimmer, Inc. | 2000-03-10 |