Z-1318-2016 Class II Terminated
FDA device recall Z-1318-2016 was initiated by Biomet, Inc. on Mar 9, 2016 and is designated Class II. Reason for recall: Inadequate design control. The recall status is terminated (terminated May 23, 2017). Affected quantity: 576.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2016
- Initiation Date
- Mar 9, 2016
- Termination Date
- May 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 576
Product Description
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Reason for Recall
Inadequate design control.
Distribution Pattern
US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1318-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026