Z-2238-2016Class II

2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following...

Name: Z-2238-2016 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-06-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-06-24 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and... on 2016-06-24. FDA classified it as Class II and gives the reason as "A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical...". 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-2238-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-24
Posted: 2016-07-19
Terminated: 2017-03-23
Recalling firm: Stryker Corp.
Product: 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. They are intended to be used with the Stryker CORE" system.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker sent an Urgent Medical Device Recall Notification letter dated June 24, 2016, to the affected customers via courier, and to Sales Representatives and international affiliates via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at 269-389-2921.
Quantity in commerce: 3,163
Distribution: Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
Product codes and lots: Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2238-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2238-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-19

Product code HBE

K143399Class IIStryker Footed Attachments and Cutting AccessoriesStryker Corp. / cleared 2015-05-08

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)