FDA-Device2015-08-12Class II
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
The Anspach Effort, Inc.
Hazard
Saw head separated from the drive unit or began to come loose.
Sold states
Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom.
Affected count
360 handpieces (Currently there are 9 affected units remaining in the US and 17 units OUS all others were reworked)
Manufactured in
4500 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2345-2015Don't want to check this manually?
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