stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
FDA device recall Z-0982-2025 · posted 2025-01-17 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- 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).
- 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."
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HBE
- Quantity affected
- 1489 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
- Date initiated
- 2023-06-28
- Date posted
- 2025-01-17
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K143320) | Stryker Corp. | 2015-04-23 |