Recall Z-2599-2017 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
| Date | Apr 28, 2017 |
| Status | Terminated |
| Reason | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet initiated a voluntary recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Compromised packaging may result in surgical delays, possible infections, and revision surgeries due to infections. The firm distributed letters to customer via FED EX on 04/28/2017. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknow |
| Quantity | 1707 |
| Distribution | Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083497 | ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS Zimmer, Inc., Feb 19, 2009 |