Recall Z-0063-2025 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Corporation
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
| Date | Oct 11, 2024 (initiated Sep 5, 2024) |
| Status | Open, Classified |
| Reason | May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk. |
| Root cause | Process control |
| Action | Stryker issued Urgent Medical Device Recall Letter on 9/5/24 via FedEx 2-day to Recall Department, Materials Manager, OR Director, Risk Manager. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A repl |
| Quantity | 307 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker Corp., Apr 23, 2015 |