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
FDA Recall Z-1321-2016 · Posted 2016-04-05
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Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2016-03-03
Date Terminated2017-05-17
Product Quantity26,903 devices
Reason for Recall
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.
Firm Action
Consignees were notified via letter on 3/3/2016. Consignees were instructed to quarantine the recalled products and complete an Inventory Return Certification Form.
Root Cause
Package design/selection
Distribution Pattern
Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, China, Hong Kong, India, Lebanon, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arabic Emirates, Vietnam, Australia, Japan, New Zealand, Brazil, and Chile.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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