Reported Apr 13, 2016 · Terminated
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- All instrumentation associated with the Prelude PF Resurfacing Knee System.
- Lot codes and dates
- All Lots of All Prelude PF instrumentation part numbers
- Part Number Description 110004338No. 1 Femoral Trial
- Left 110004248No. 1 Femoral Trial
- Right 110004339No. 2 Femoral Trial
- Left 110004250No. 2 Femoral Trial
- Right 110004344No. 3 Femoral Trial
- Left 110004252No. 3 Femoral Trial
- Right 110004342No. 4 Femoral Trial
- Left 110004254No. 4 Femoral Trial
- Right 110004341No. 5 Femoral Trial
- Left 110004256No. 5 Femoral Trial
- Right 110004337No. 6 Femoral Trial
- Left 110004258No. 6 Femoral Trial
- Right 110004340No. 6W Femoral Trial
- Left 110004260No. 6W Femoral Trial
- Right 110004343No. 7W Femoral Trial
- Left 110004262No. 7W Femoral Trial
- Right 110004345No. 8W Femoral Trial
- Left 110004264No. 8W Femoral Trial
- Right 110004105No. 1 Drill Guide
- Left 110004106No. 1 Drill Guide
- Right 110004107No. 2 Drill Guide
- Left 110004108No. 2 Drill Guide
- Right 110004109No. 3 Drill Guide
- Left 110004110No. 3 Drill Guide
- Right 110004111No.4 Drill Guide
- Left 110004112No.4 Drill Guide
- Right 110004113No. 5 Drill Guide
- Left 110004114No. 5 Drill Guide
- Right 110004115No. 6 Drill Guide
- Left 110004116No. 6 Drill Guide
- Right 110004117No. 6W Drill Guide
- Left 110004118No. 6W Drill Guide
- Right 110004119No. 7W Drill Guide
- Left 110004120No. 7W Drill Guide
- Right 110004121No. 8W Drill Guide
- Left 110004122No. 8W Drill Guide
- Right 01000176325MM
- Reamer 01000176831MM
- Reamer 11000415125MM
- Stop Collar 11000416531MM
- Stop Collar 110007428Stop
- Collar Push Button 1100041702.1MM
- Guide Pin 110004169Trial
- Remover 110004172Impactor
- Handle 11000739815
- Degree Rasp 597004Instrument
- Case 11001882025MM
- Peek Bushing 11001882131MM Peek Bushing
- Amount recalled
- 576
Where it was sold
Why it was recalled
Inadequate design control.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Biomet, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.