Z-2420-2010

Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur Guard is intended...

Name: Z-2420-2010 Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur Guard is intended...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2010-06-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-06-02 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is... on 2010-06-02. The reason FDA records is "The reason for the field action is that the inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2420-2010
Status: Terminated
Initiated: 2010-06-02
Posted: 2010-09-13
Terminated: 2011-04-21
Recalling firm: Stryker Corp.
Product: Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: The reason for the field action is that the inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come into contact with the Nose Cone of the drill. This could result in an injury or burn to the patient and/or user.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Instruments sent an Urgent Medical Device Recall Notification dated June 10, 2010, to their customers. The letter described the product the problem and the action to be taken by the customers. The customers were instructed to: 1) immediately review this recall notification. 2) forward this letter and the attached Business Reply Form (BRF) to all affected locations. 3) Immediately check and quarantine any affected product found. 4) Destroy all affected product by breaking off at least 3 of the tabs on the bur guard and then dispose of the affected product in normal trash. 5) Complete and sign the BRF and fax to Stryker Instruments Regulatory Department, 866-521-2762. NOTE: Upon receipt of the BRF, a replacement bur guard will be sent to the customer's account for each affected bur guard destroyed. For questions regarding this recall please contact Stryker Instruments: 1-800-800-4236, ext. 3808 [email protected]
Quantity in commerce: 10982
Distribution: Worldwide Distribution: US AND COUNTRIES OF SCANDINAVIA, AUSTRALIA, CANADA, CHILE, CHINA, BRAZIL, FRANCE, GERMANY, GREECE, SOUTH AFRICA, ITALY, JAPAN, MEXICO, SWITZERLAND, PORTUGAL, SINGAPORE and UK.
Product codes and lots: Replace by dates of May 2009 through August 2010

Product code HWE

K961970Class ICommand 2 Micoelectric Surgical SystemStryker Corp. / cleared 1996-07-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)