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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 Systemsee related information
Date Initiated by FirmMarch 09, 2016
Date PostedApril 04, 2016
Recall Status1 Terminated 3 on May 23, 2017
Recall NumberZ-1318-2016
Recall Event ID 73489
510(K)NumberK123907 K143543 
Product Classification Prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer - Product Code KRR
ProductAll 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 ContactAudrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		Inadequate design control.
FDA Determined
Cause 2		Device Design
ActionZimmer 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 Commerce576
DistributionUS Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRR
510(K)s with Product Code = KRR
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