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Terminated

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

FDA Recall Z-1814-2016 · Posted 2016-05-25

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2016-04-11
Date Terminated2017-05-30
Product Quantity22

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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