FDA Medical Device Recalls (openFDA)
Biomet, Inc.: PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
- Recall number
- Z-1814-2016
- Recalling firm
- Biomet, Inc.
- Product
- PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
- Status
- Terminated
- Initiated
- 2016-04-11
- Posted
- 2016-05-25
- Terminated
- 2017-05-30
- 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 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
- 22
- Distribution
- Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.
- Lot, serial or model codes
- PerFuse Decompression Instrument PN: 800-0541, Lot:100650
- 510(k) numbers
- ["K141762"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28