Arthrex Burr — Class II medical device recall Z-1206-2019
Terminated recall by Arthrex, Inc., reported 2019-05-01, distributed nationwide. Devices may generate excessive heat during use.
| Recall number | Z-1206-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2019-01-14 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2023-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, DE |
| Quantity | 2,324 |
| Lot numbers | 10211276 |
| Expiration dates | 2023-03-31, 2023-04-30 |
Product
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
Reason for recall
Devices may generate excessive heat during use.
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-1206-2019. 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.