FDA Device recall Z-2205-2016
6.0mm Round Fluted Bur, Super Long
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of 6.0mm Round Fluted Bur, Super Long by Stryker Instruments Div, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2205-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-16 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Instruments Div |
| Distribution | CA, IL, SD |
Product
6.0mm Round Fluted Bur, Super Long
Reason
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.
Identifiers
| code_info | 5190-010-060 Lot Numbers 15231017, 16033017, 16066017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2205-2016%22
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