Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1814-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

Product Classification:

Class II

Date Initiated: April 11, 2016

Date Posted: June 1, 2016

Recall Number: Z-1814-2016

Event ID: 74025

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.

Status: Terminated

Product Quantity: 22

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.

Voluntary or Mandated:

Voluntary: Firm initiated