Recall Z-0869-2017 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Instruments Div. of Stryker Corporation
8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and rem
| Date | Dec 21, 2016 (initiated Nov 30, 2016) |
| Status | Terminated |
| Reason | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. |
| Root cause | Storage |
| Action | The firm, Stryker Instruments, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 2016 to its Customers Overnight service, FedEx on November 30, 2016. The letter described the product, problems and actions to be taken. Stryker Sales Representatives and Stryker International will be notified via email. Customers are instructed to do the following: 1. Immediately review the Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many affected Burs from the affected lots are at your facility. Quarantine and discontinue use of the rec |
| Quantity | 1,257 in total |
| Distribution | Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.