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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 2.3mm Tapered Router

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 Class 2 Device Recall Stryker 2.3mm Tapered Routersee related information
Date Initiated by FirmJune 24, 2022
Create DateJuly 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1478-2022
Recall Event ID 90535
510(K)NumberK143320 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductStryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Code Information UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027
Recalling Firm/
Manufacturer		 Stryker Instruments
1941 Stryker Way
Portage MI 49002
For Additional Information ContactJordan Anderson
269-800-1347
Manufacturer Reason
for Recall		There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
FDA Determined
Cause 2		Process change control
ActionOn June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters. Customers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product.
Quantity in Commerce543
DistributionWorldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.
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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