Recalls / —
—#146013
Product
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K141762
- Affected lot / code info
- PerFuse Decompression Instrument PN: 800-0541, Lot:100650
Why it was recalled
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Timeline
- Recall initiated
- 2016-04-11
- Posted by FDA
- 2016-05-25
- Terminated
- 2017-05-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.