Recall Z-1814-2016 ยท FMF Syringe, Piston
Biomet, Inc.
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
| Date | May 25, 2016 (initiated Apr 11, 2016) |
| Status | Terminated |
| Reason | The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes. |
| 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 CPWARFieldAction@zimmerbiomet.com; Adverse reactions or quality problems experienced with the use of this product may be reported to the |
| Quantity | 22 |
| Distribution | Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141762 | PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM Biomet, Inc., Aug 27, 2014 |