Recall Z-0440-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
| Date | Aug 7, 2017 |
| Status | Terminated |
| Reason | During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. |
| Root cause | Process change control |
| Action | Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed. |
| Quantity | 638 units |
| Distribution | US nationwide distribution. Also Portugal and the Netherlands. |
| 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 |