TOPAZ MicroDebrider 0 — Class II medical device recall Z-1321-2016
Terminated recall by ArthroCare Corporation, reported 2016-04-13, distributed nationwide. During functional testing of devices after real time aging, it was determined that product failed to meet shel
| Recall number | Z-1321-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ArthroCare Corporation, Austin, TX, United States |
| Recall initiated | 2016-03-03 |
| Classified | 2016-04-05 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CL, CN, DE, DK, EE, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, LB, LV, NL, NO, NZ, PL, PT, RU, SA, SE, SG, TH, TR, TW, VN, ZA |
| Quantity | 26,903 devices |
| Reason classes | labeling |
| Model numbers | AC4040-01, ACH4040-01, Q6000-01, Q6002-01 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1321-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.