Z-2205-2016Class II

6.0mm Round Fluted Bur, Super Long

Name: Z-2205-2016 6.0mm Round Fluted Bur, Super Long
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-06-16
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-06-16 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 6.0mm Round Fluted Bur, Super Long on 2016-06-16. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2205-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-16
Posted: 2016-07-14
Terminated: 2017-06-06
Recalling firm: Stryker Corp.
Product: 6.0mm Round Fluted Bur, Super Long
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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 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 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
Product codes and lots: 5190-010-060 Lot Numbers 15231017, 16033017, 16066017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2205-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2204-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-14
Z-2205-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-14

Product code HBE

K143320Class IIStryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. / cleared 2015-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)