PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
FDA device recall Z-1814-2016 · posted 2016-05-25 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 22
- Distribution
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
- Date initiated
- 2016-04-11
- Date posted
- 2016-05-25
- Date terminated
- 2017-05-30
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM (K141762) | Biomet, Inc. | 2014-08-27 |