—#92243

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.

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K961970
Affected lot / code info: Replace by dates of May 2009 through August 2010

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-06-02
Posted by FDA: 2010-09-13
Terminated: 2011-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.