Reported Apr 13, 2016 · Terminated
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF…
ArthroCare Corporation
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: ArthroCare Corporation · 7000 W William Cannon Dr Bldg 1 · Austin, TX · 78735-8509
Is this the product you have?
- TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
- Lot codes and dates
154 of 154 codes
103150610315071032123103232510327411032742103344310339651033966103439710391201041765104408910440901045862104823710489331049185105207110562121060586106097910633941064599106769610677481069174107135810741251075714107052110708121071974107802510774991082811108409510840941085458108643610864371087917109431310975731103824110718311072971113562111356311145341114535111453611158961031518103230810323091032310103275510327561033972
- Amount recalled
- 26,903 devices
Where it was sold
- Nationwide
Why it was recalled
During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.
This product could cause temporary or reversible health problems — stop using it.
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