Cushing burrs are bone cutting and drilling instruments that are used… — Class II medical device recall Z-0543-2015
Terminated recall by Instrumed International, Inc., reported 2014-12-17, distributed nationwide. The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market the
| Recall number | Z-0543-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumed International, Inc., Schaumburg, IL, United States |
| Recall initiated | 2014-09-08 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2017-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 4 cushing |
| Lot numbers | 060311 |
| Model numbers | MF223-1592, MF223-1597, SS2133 |
Product
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Reason for recall
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
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-0543-2015. 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.