Z-2204-2016 Class II Terminated
FDA device recall Z-2204-2016 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 16, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jun 6, 2017). Affected quantity: 25.
Recall details
- Product Type
- Devices
- Report Date
- Jul 20, 2016
- Initiation Date
- Jun 16, 2016
- Termination Date
- Jun 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product description
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.
Distribution pattern
US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
Code information
5190-010-050 5.0mm Round Fluted Bur, Super Long , Lot Number: 15322017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2204-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026