Z-1814-2016Class II

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

Name: Z-1814-2016 PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for...
Creator: Biomet, Inc.
Published: 2016-04-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-04-11 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression on 2016-04-11. FDA classified it as Class II and gives the reason as "The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1814-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-11
Posted: 2016-05-25
Terminated: 2017-05-30
Recalling firm: Zimmer GmbH
Product: PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Product code: FMF Syringe, Piston
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet has initiated a voluntary recall of the PerFuse Decompression Instrument, following an investigation which identified that the Trocar and Plunger Assemblies are missing from the instrument. The firm contacted customers via telephone and e-mail on March 28, 2016; and official recall notices were mailed via FedEx on 4/11/2016. Customers were instructed to quarantine recalled items, Complete the Certificate of Acknowledgment and email a copy to [email protected]; Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or Call (800)FDA-1088 . Questions related to this recall should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 22
Distribution: Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Product codes and lots: PerFuse Decompression Instrument PN: 800-0541, Lot:100650

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1814-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1814-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-25

Product code FMF

K141762Class IIPerfuse Percutaneous Decompression SystemBiomet, Inc. / cleared 2014-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)