Class 2 Device Recall 5.0mm Round Fluted Bur, Super Long

• Date Initiated by Firm: June 16, 2016
• Date Posted: July 14, 2016
• Recall Status: Terminated on June 06, 2017
• Recall Number: Z-2204-2016
• Recall Event ID: 74562
• 510(K)Number: K143320
• Product Classification: Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
• Product: 5.0mm Round Fluted Bur, Super Long
• Code Information: 5190-010-050  5.0mm Round Fluted Bur, Super Long , Lot Number: 15322017
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kara Spath; 269-389-4518
• Manufacturer 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.
• FDA Determined 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 to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many affected Round Fluted Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Round Fluted Burs. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4 If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Report any serious adverse events or product quality problems to Stryker Instruments: 1-800-253-3210 Health care professionals and consumers
• Quantity in Commerce: 25
• Distribution: US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HBE