PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Reported: June 1, 2016 Initiated: April 11, 2016 #Z-1814-2016
Product Description
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Reason for Recall
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 22
- Distribution
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.. Recalled by Biomet, Inc.. Units affected: 22.
Why was this product recalled? ▼
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1814-2016.
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