All instrumentation associated with the Prelude PF Resurfacing Knee System.
Reported: April 13, 2016 Initiated: March 9, 2016 #Z-1318-2016
Product Description
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Reason for Recall
Inadequate design control.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 576
- Distribution
- US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
All instrumentation associated with the Prelude PF Resurfacing Knee System.. Recalled by Biomet, Inc.. Units affected: 576.
Why was this product recalled? ▼
Inadequate design control.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1318-2016.
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