Recall Z-2420-2010 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
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 min
| Date | Sep 13, 2010 (initiated Jun 2, 2010) |
| Status | Terminated |
| Reason | 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 | 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) Co |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961970 | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM Stryker Corp., Jul 26, 1996 |