Reported Jul 4, 2012 · Terminated
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker…
Stryker Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
- Lot codes and dates
- Formula Shaver Hand Control, PN 375-704-500 and Formula 180 (PN 375-708-500)
- Serial numbers
12B03720412B03721412B03722412B03723412B04059412B04060412B04061412B04062412B04063412B04064412B04065412B04066412B04068412B04137412B04693412B04696412B04697412B04699412B04700412B04701412B04702412B04703412B04705412B04706412B04707412B04708412B04709412B04920412B04923412B04924412B05574412B05575412B05576412B055774
- Amount recalled
- 34 devices
Where it was sold
Why it was recalled
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
This product could cause temporary or reversible health problems — stop using it.
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