Z-1814-2016 Class II Terminated
FDA device recall Z-1814-2016 was initiated by Biomet, Inc. on Apr 11, 2016 and is designated Class II. 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. The recall status is terminated (terminated May 30, 2017). Affected quantity: 22.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2016
- Initiation Date
- Apr 11, 2016
- Termination Date
- May 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
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.
Distribution Pattern
Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Code Information
PerFuse Decompression Instrument PN: 800-0541, Lot:100650
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1814-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026