—#211721

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.

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K143320
Affected lot / code info: GTIN 04546540362483, Lot Number 21341057

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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."

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.

Timeline

Recall initiated: 2023-06-28
Posted by FDA: 2025-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211721. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.