Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

FDA Recall Z-0982-2025 · Posted 2025-01-17

Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeHBE
Date Initiated2023-06-28
Product Quantity1489 units

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).

Firm Action

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 [email protected]. 3. Upon receiving your Business Response Form to the email, [email protected], 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 [email protected] with questions or concerns."

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑