Recall Z-0980-2025 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Corporation
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) i
| Date | Jan 17, 2025 (initiated Jun 28, 2023) |
| Status | Open, Classified |
| Reason | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device). |
| Root cause | Process control |
| Action | Stryker issued a Medical Device Recall notice to its consignees on 06/28/2024 via FedEx. The notice explained the issue and requested the following actions be taken: "1. Review your inventory to locate and quarantine any affected products found on-hand. 2. Sign and return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email Instruments.recalls@stryker.com. 3. Upon receiving your Business Reply Form to the email, Instruments.recalls@stryker.com, a shipping label will be provided to return any recalled product on-hand. 4. Maintain awareness |
| Quantity | 491 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK. |
| 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 |