Recall Z-0448-2019 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
| Date | Oct 2, 2018 |
| Status | Terminated |
| Reason | The set screw is not able to advance or reverse from the original position in the nail. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL LOT SPECIFIC" notification letters dated 10/2/18 to customers. The letters described the product, problem and actions to be taken. The customers were instructed to 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgemen |
| Quantity | 2,163 in total (expanded) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DePuy Orthopaedics, Inc., May 11, 2010 |