Recall Z-1238-2018 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal
| Date | Nov 29, 2017 |
| Status | Terminated |
| Reason | Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer Biomet sent an Urgent Medical Device Correction Recall letter dated November 29, 2017. RISK MANAGER PHASE I: 1. Review this notification and notify affected personnel of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated (Phase 2). If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. Complete Certificate of Acknowledgement (Phase 1) a |
| Quantity | 1023 |
| Distribution | USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161592 | Persona Partial Knee System Biomet, Inc., Nov 3, 2016 |