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U.S. Department of Health and Human Services

Class 2 Device Recall Persona Partial Knee

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  Class 2 Device Recall Persona Partial Knee see related information
Date Initiated by Firm November 29, 2017
Create Date March 28, 2018
Recall Status1 Terminated 3 on April 05, 2019
Recall Number Z-1238-2018
Recall Event ID 79383
510(K)Number K161592  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product 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.
Code Information (1) 8mm block, Model Number: 42-5399-035-08, Lots: 63767442 and 63807190; (2) 9mm block, Model Number:42-5399-035-09, Lot: 63769804; (3) 10mm block, Model Number: 42-5399-035-10, Lot: 63769805; (4) 12mm block, Model Number: 42-5399-035-12, Lot: 63769806; (5) 14mm block, Model Number: 42-5399-035-14, Lots: 63767443 and 63813674
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
571-371-3071
Manufacturer Reason
for Recall		 Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
FDA Determined
Cause 2		 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) and send to CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSX and Original Applicant = BIOMET, INC.
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