TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF
FDA device recall Z-1321-2016 · posted 2016-04-05 · Terminated
Recall details
- Recalling firm
- ArthroCare Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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, It
- Date initiated
- 2016-03-03
- Date posted
- 2016-04-05
- Date terminated
- 2017-05-17
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; (K080282) | Arthrocare Corp. | 2008-02-15 |