Z-0063-2025Class II

1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and...

Name: Z-0063-2025 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and...
Creator: Stryker Corporation
Published: 2024-09-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-09-05 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety... on 2024-09-05. FDA classified it as Class II and gives the reason as "May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0063-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-05
Posted: 2024-10-11
Recalling firm: Stryker Corp.
Product: 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker issued Urgent Medical Device Recall Letter on 9/5/24 via FedEx 2-day to Recall Department, Materials Manager, OR Director, Risk Manager. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. 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. If you have any questions about this matter, contact Stryker Instruments recall team directly by calling (269) 568-1481 or email at [email protected].
Quantity in commerce: 307 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
Product codes and lots: GTIN: 04546540362346 Lot number: 22329017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0063-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0063-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-11

Product code HBE

K143320Class IIStryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. / cleared 2015-04-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)