Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
FDA device recall Z-2244-2014 · posted 2014-08-16 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Action taken
- On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 47,682 units total
- Distribution
- National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA
- Date initiated
- 2014-07-22
- Date posted
- 2014-08-16
- Date terminated
- 2015-06-18
- 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 PLATES AND SCREWS SYSTEM SCREWS ONLY (K112885) | Zimmer, Inc. | 2011-12-19 |