Recall Z-1236-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
| Date | Mar 27, 2018 (initiated Mar 12, 2018) |
| Status | Terminated |
| Reason | Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant. |
| Root cause | Device Design |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" notice dated 3/12/2018 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: Risk Manager: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative and quarantine all affected product. 3. Zimmer Biomet sales representative will remove the affected product from the facility. 4. Complete Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postma |
| Quantity | 2470 |
| Distribution | Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia, Brazil, Canada, Chile, Colombia, El Salvador, Netherlands, Japan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091976 | BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL Biomet Trauma, Aug 17, 2009 |