Z-0874-2017Class II

8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery)...

Name: Z-0874-2017 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery)...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-11-30
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-11-30 / Terminated / root cause: sterility

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material... on 2016-11-30. FDA classified it as Class II and gives the reason as "Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0874-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-30
Posted: 2016-12-21
Terminated: 2017-06-01
Recalling firm: Stryker Corp.
Product: 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Root cause tag: sterility
FDA root cause: Storage
Action: The firm, Stryker Instruments, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 2016 to its Customers Overnight service, FedEx on November 30, 2016. The letter described the product, problems and actions to be taken. Stryker Sales Representatives and Stryker International will be notified via email. Customers are instructed to do the following: 1. Immediately review the Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many affected Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Burs. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of the notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to [email protected]. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to [email protected]. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Recalled products will be destroyed, packaging will be defaced, opened and discarded. Product will be discarded. For questions regarding this recall, please contact Stryker Instruments: [email protected], or
Quantity in commerce: 1,257 in total
Distribution: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
Product codes and lots: Lot Number:16029017, Product Number: 8450-009-040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0874-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0868-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21
Z-0869-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21
Z-0870-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21
Z-0871-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21
Z-0872-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21
Z-0873-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21
Z-0874-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21

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)