stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
- Company
- Stryker Corporation
- Recall Initiated
- June 28, 2023
- Posted
- January 17, 2025
- Recall Number
- Z-0982-2025
- Quantity
- 1489 units
- Firm Location
- Portage, MI
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 5820-107-430 but package contains a 5820-107-530 device or vice versa).
Distribution
Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Lot / Code Info
GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017
Root 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 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."