PerFuse Decompression Instrument PN: 800-0541, Lot:100650.… recallZ-1814-2016 · Biomet, Inc. · initiated Apr 11, 2016
Class II Terminated All recalls posted in May 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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 [email protected]; 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.
Recall details
- Recall number
- Z-1814-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 11, 2016
- Posted by the FDA
- May 25, 2016
- Recalling firm
- Biomet, Inc.
- Quantity
- 22
- Product code
- FMF
- FDA submissions
- K141762
- Distribution
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
Product description
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
Code information (models, lots, serial numbers)
PerFuse Decompression Instrument PN: 800-0541, Lot:100650
Other devices under the same FDA submission
1 device cleared under K141762 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PerFuse™ Percutaneous Decompression System 800-0541Biomet Orthopedics, LLC · Syringe, piston1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page