Stryker Corporation recalls stryker 3.0MM Precision Neuro Match Head

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

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 to be taken 1. Review your inventory to locate and quarantine any affected products found on-hand. 2. Sign and return the enclosed Business Response Form (BRF), even if affected product is no longer in inventory, to the email Instruments.recalls@stryker.com. 3. Upon receiving your Business Response 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."

• FDA enforcement recordOfficial FDA database entry for Z-0982-2025
• FDA 510(k) clearance · K143320The device's official FDA premarket clearance record
• FDA device classification · HBEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4310The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.