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U.S. Department of Health and Human Services

Class 2 Device Recall PerFuse Decompression Instrument

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  Class 2 Device Recall PerFuse Decompression Instrument see related information
Date Initiated by Firm April 11, 2016
Date Posted May 25, 2016
Recall Status1 Terminated 3 on May 30, 2017
Recall Number Z-1814-2016
Recall Event ID 74025
510(K)Number K141762  
Product Classification Syringe, piston - Product Code FMF
Product PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Code Information PerFuse Decompression Instrument PN: 800-0541, Lot:100650
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-372-1683
Manufacturer 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.
FDA Determined
Cause 2		 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 CPWARFieldAction@zimmerbiomet.com; 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = BIOMET, INC.
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