Device product
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Z-1814-2016
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 74025
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22
- Official record key
device-enforcement:Z-1814-2016
Official wording
Reason: The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Code information: PerFuse Decompression Instrument PN: 800-0541, Lot:100650
Distribution pattern: Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Derived failure modes
-
Unknown
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.