Recall Z-0980-2025
Stryker Corporation · initiated June 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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) 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. These burs are sold as single use devices without their own IFU.
Codes / lots: GTIN 04546540362483, Lot Number 21341057
Reason for recall
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).
FDA-determined cause: Process control
Action taken
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 of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Jordan Anderson at (269) 800-1347 or Instruments.recalls@stryker.com with questions or concerns."
Details
- Recall number
- Z-0980-2025
- Initiated
- June 28, 2023
- Posted by FDA
- January 17, 2025
- Product code
- HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Quantity
- 491 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
- Recalling firm
- Stryker Corporation, Portage, MI