8470-009-040 4 — Class II medical device recall Z-0871-2017
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-12-28, distributed nationwide. Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may
| Recall number | Z-0871-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2016-11-30 |
| Classified | 2016-12-21 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, GB, JP, NL |
| Quantity | 1,257 in |
| Reason classes | sterility |
| Lot numbers | 16038017 |
Product
8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
Reason for recall
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
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-0871-2017. 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.