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 femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.

Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.

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) and send to [email protected]. SURGEON PHASE I: 1. Review this notification for awareness of the contents. 2. The spacer block may be used without the alignment tower and inserted and removed by hand from the joint, without the Persona Partial Knee handle. 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. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 4. Complete Certificate of Acknowledgement (Phase 1) and send to [email protected]. DISTRIBUTOR PHASE I: 1. Review this notification and notify affected team 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. 3. Should you or your account prefer to perform a functional check, this may be done by using the instructions in the surgical technique for assembling the alignment tower and handle to the spacer block. If you or your account identify a spacer block that will not assemble with these instruments, and the user is unwilling to use the spacer block without this functionality, the spacer block may be returned as a complaint to Pr