| Class 2 Device Recall PerFuse Decompression Instrument | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FMF
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