Recall Z-2247-2014 ยท HWC Screw, Fixation, Bone
Zimmer, Inc.
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
| Date | Aug 16, 2014 (initiated Jul 22, 2014) |
| Status | Terminated |
| Reason | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 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, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112885 | ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY Zimmer, Inc., Dec 19, 2011 |