Recall Z-1814-2016— Biomet, Inc.

Name: FDA recall Z-1814-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-11

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2016-04-11, terminated 2017-05-30. It names one FDA 510(k) clearance: K141762. Product: PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.. Reason: The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-11
Terminated: 2017-05-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K141762 — PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEMBiomet, Inc.·cleared 2014-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.