Recalls / —

—#144285

Product

All instrumentation associated with the Prelude PF Resurfacing Knee System.

FDA product code

KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K123907, K143543

Affected lot / code info

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

Why it was recalled

Inadequate design control.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.

Timeline

Recall initiated

2016-03-09

Posted by FDA

2016-04-04

Terminated

2017-05-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #144285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.