Recall Z-1321-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Corporation
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
| Date | Apr 5, 2016 (initiated Mar 3, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Package design/selection |
| 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. |
| Quantity | 26,903 devices |
| Distribution | 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, In |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; Arthrocare Corp., Feb 15, 2008 |