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

FDA device recall Z-2420-2010 · posted 2010-09-13 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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 jennifer.mars@stryker.com

Root cause

Device Design

Status

Terminated

Product code

HWE

Quantity affected

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.

Date initiated

2010-06-02

Date posted

2010-09-13

Date terminated

2011-04-21

Location

Kalamazoo, MI

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