5 — Class II medical device recall Z-2204-2016
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2016-07-20, distributed in CA, IL, SD. Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or c
| Recall number | Z-2204-2016 |
|---|---|
| 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 | 2016-06-16 |
| Classified | 2016-07-14 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-06-06 |
| Distributed | CA, IL, SD |
| Countries outside the US | CA, NL |
| Quantity | 25 |
| Reason classes | foreign material |
| Lot numbers | 15322017 |
Product
5.0mm Round Fluted Bur, Super Long
Reason for recall
Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
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-2204-2016. 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.