Z-2418-2019Class II

Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar...

Name: Z-2418-2019 Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar...
Creator: Stryker GmbH
Published: 2019-07-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-07-25 / Terminated / root cause: packaging

FDA source

Stryker GmbH began a recall of Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive... on 2019-07-25. FDA classified it as Class II and gives the reason as "The seal integrity of the sterile bag containing the kits may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2418-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-25
Posted: 2019-08-28
Terminated: 2020-09-24
Recalling firm: Stryker Corp.
Product: Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
Product code: HRX Arthroscope
Reason for recall: The seal integrity of the sterile bag containing the kits may be compromised.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Stryker, sent an "UPDATE URGENT MEDICAL DEVICE RECALL" notification letters dated 7/25/19 were to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-855-207-2792 or email to [email protected] 5. Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns (Ref# PFA 2042684) Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. If you have any questions, please contact Director Post Market Compliance and Quality System at 201-831-5151 or [email protected]; your local Sales Office or the Stryker Sales Representative for assistance.
Quantity in commerce: 2248
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers 01403, 01466, 01483

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2418-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2412-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2413-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2414-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2415-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2416-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2417-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2418-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2419-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2420-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2421-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2422-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2423-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2424-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

Product code HRX

K940230Class IIEndoscopic Mortons Neuroma InstrumentsInstratek, Inc. / cleared 1994-12-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)