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U.S. Department of Health and Human Services

Class 2 Device Recall Prelude Patella Femoral Resurfacing Knee System

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  Class 2 Device Recall Prelude Patella Femoral Resurfacing Knee System see related information
Date Initiated by Firm March 09, 2016
Date Posting Updated April 04, 2016
Recall Status1 Terminated 3 on May 23, 2017
Recall Number Z-1318-2016
Recall Event ID 73489
510(K)Number K123907  K143543  
Product Classification Prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer - Product Code KRR
Product All instrumentation associated with the Prelude PF Resurfacing Knee System.

Code Information All Lots of All Prelude PF instrumentation part numbers.

Part Number Description, 110004338: No. 1 Femoral Trial, Left , 110004248: No. 1 Femoral Trial, Right , 110004339: No. 2 Femoral Trial, Left, 110004250: No. 2 Femoral Trial, Right, 110004344: No. 3 Femoral Trial, Left, 110004252: No. 3 Femoral Trial, Right, 110004342: No. 4 Femoral Trial, Left, 110004254: No. 4 Femoral Trial, Right, 110004341: No. 5 Femoral Trial, Left, 110004256: No. 5 Femoral Trial, Right, 110004337: No. 6 Femoral Trial, Left, 110004258: No. 6 Femoral Trial, Right, 110004340: No. 6W Femoral Trial, Left, 110004260: No. 6W Femoral Trial, Right, 110004343: No. 7W Femoral Trial, Left, 110004262: No. 7W Femoral Trial, Right, 110004345: No. 8W Femoral Trial, Left, 110004264: No. 8W Femoral Trial, Right, 110004105: No. 1 Drill Guide, Left , 110004106: No. 1 Drill Guide, Right, 110004107: No. 2 Drill Guide, Left , 110004108: No. 2 Drill Guide, Right, 110004109: No. 3 Drill Guide, Left , 110004110: No. 3 Drill Guide, Right, 110004111: No.4 Drill Guide, Left, 110004112: No.4 Drill Guide, Right, 110004113: No. 5 Drill Guide, Left, 110004114: No. 5 Drill Guide, Right, 110004115: No. 6 Drill Guide, Left, 110004116: No. 6 Drill Guide, Right, 110004117: No. 6W Drill Guide, Left, 110004118: No. 6W Drill Guide, Right, 110004119: No. 7W Drill Guide, Left, 110004120: No. 7W Drill Guide, Right, 110004121: No. 8W Drill Guide, Left, 110004122: No. 8W Drill Guide, Right, 010001763: 25MM Reamer, 010001768: 31MM Reamer, 110004151: 25MM Stop Collar, 110004165: 31MM Stop Collar, 110007428: Stop Collar Push Button, 110004170: 2.1MM Guide Pin, 110004169: Trial Remover, 110004172: Impactor Handle, 110007398: 15 Degree Rasp, 597004: Instrument Case, 110018820: 25MM Peek Bushing, 110018821: 31MM Peek Bushing.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall
Inadequate design control.
FDA Determined
Cause 2
Device Design
Action Zimmer Biomet sent an "Urgent Medical Device Recall Notice" dated March 9, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: 1. Immediately locate and remove the identified device(s) listed below from circulation. 2. Carefully follow the instructions on the enclosed Response Form. 3.Email a copy of the response form to CPW ARFieldAction@zimmerbiomet.com prior to return of product. 4. Use priority carrier for your shipment. Please confirm receipt of this notice by sending back the response form within three (3) business days. Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 576
Distribution US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
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 = KRR and Original Applicant = BIOMET INC.
510(K)s with Product Code = KRR and Original Applicant = BIOMET MANUFACTURING CORP.
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