Recall Z-2730-2024 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Corporation
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-107-030D
| Date | Aug 26, 2024 (initiated Jul 24, 2024) |
| Status | Completed |
| Reason | Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention. |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall letter on 7/24/424 to Materials Manager, Risk Manager, OR Director via Fed'x. Letter states reason for recall, health risk, and action to take: 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 credit will be provided upon receipt of |
| Quantity | 2507 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210377 | Stryker iBur hubs and cutting accessories Stryker Corporation, Jun 30, 2021 |