Z-1756-2014Class II

Stryker 3.0mm Round Fluted Bur Aggressive Sterile

Name: Z-1756-2014 Stryker 3.0mm Round Fluted Bur Aggressive Sterile
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2014-05-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-05-22 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery... on 2014-05-22. FDA classified it as Class II and gives the reason as "There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1756-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-22
Posted: 2014-06-11
Terminated: 2015-05-06
Recalling firm: Stryker Corp.
Product: Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Instruments sent an URGENT MEDICAL DEVICE RECALL notification letter dated May 22, 2014, to the consignees. Recall notification included affected product description and identification, reason for recall, risk to health, and actions to be taken by the customers. Customers will be instructed to review the notification, quarantine unused product and to return a signed Business Reply Form. They will be advised that a Stryker Representative will be sent to their facility to inspect any affected product on hand. Once product is inspected by the Stryker Representative, they can return conforming product back to stock, for normal use. Non-conforming product will be removed from the facility by a Stryker Representative following the inspection process. The Stryker Representative will send the product to the manufacturer for destruction. For questions regarding this recall please contact Stryker Instruments: Kara Spath 269-389-4518 [email protected]
Quantity in commerce: 285
Distribution: Worldwide Distribution - US (nationwide)
Product codes and lots: Part Number 5820-10-230, Lot Number 13343017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1756-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1749-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1750-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1751-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1752-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1753-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1754-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1755-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1756-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1757-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1758-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1759-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1760-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1761-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1762-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1763-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1764-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1765-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1766-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1767-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1768-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1769-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1770-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1771-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1772-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1773-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1774-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1775-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1776-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1777-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1778-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1779-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1780-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10

Product code HBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)