FDA-Device2017-05-10Class II
Large Craniotome Product Usage: Pneumatic system
The Anspach Effort, Inc.
Hazard
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Sold states
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Affected count
930
Manufactured in
4500 Riverside Dr, Palm Beach Gardens, FL, United States
Products
Large Craniotome Product Usage: Pneumatic system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1989-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief