6.0mm Round Fluted Bur, Super Long
Reported: July 20, 2016 Initiated: June 16, 2016 #Z-2205-2016
Product Description
6.0mm 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.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 25
- Distribution
- US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
6.0mm Round Fluted Bur, Super Long. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 25.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2016. Severity: Moderate. Recall number: Z-2205-2016.
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