Recall Z-1052-2009 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI. Intended to be used with impaction Drill. 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 we
| Date | Mar 30, 2009 (initiated Jan 27, 2009) |
| Status | Terminated |
| Reason | Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration. |
| Root cause | Process control |
| Action | Customers were notified via a Medical Device Recall Notification letter dated 1/27/09 and instructed to immediately check all stock areas or operating room storage and inspect their bur guards for an expiration date. They were also instructed to quarantine any affected product found, to indicate on the Business Reply Form the quantity of affected product on hand, to destroy any affected product found without an expiration date by breaking off at least 3 of the tabs on the bur guard, then dispose of the affected product in normal trash, and complete and return the business reply form. Custome |
| Quantity | 70 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961970 | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM Stryker Corp., Jul 26, 1996 |