Recall Z-2205-2016 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Instruments Div. of Stryker Corporation
6.0mm Round Fluted Bur, Super Long
| Date | Jul 14, 2016 (initiated Jun 16, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Stryker initiated a voluntary recall of the Stryker Round Fluted Burs (used with Stryker CORE" System) on June 16, 2016, via certified mail due to the potential for the devices to have tarnishing or corrosion present. Non-responding accounts will be contacted by phone, email, and/or fax as necessary in an effort to obtain signed Business Reply Forms. Affected product will be removed from the field. Further corrective and preventative actions will be determined through the associated CAPA. The existing label will be defaced, packaging will be opened and products will be destroyed. Actions |
| Quantity | 25 |
| Distribution | US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker Corp., Apr 23, 2015 |