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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 3.0MM Prec Neuro Match Hea

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 Class 2 Device Recall Stryker 3.0MM Prec Neuro Match Heasee related information
Date Initiated by FirmJune 28, 2023
Date PostedJanuary 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0982-2025
Recall Event ID 95998
510(K)NumberK143320 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Productstryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Code Information GTIN 07613154028177, Lot Numbers: 22179047, 22179027, 22160017
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactSylvia Page
269-501-8375
Manufacturer 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).
FDA Determined
Cause 2		Process control
ActionStryker 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."
Quantity in Commerce1489 units
DistributionWorldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HBE
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