Stryker GmbH Bohnackerweg 1 Selzach Switzerland Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-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.
Brand
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
Lot Codes / Batch Numbers
Lot Number 01401
Products Sold
Lot Number 01401
Stryker GmbH Bohnackerweg 1 Selzach Switzerland is recalling Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the trea due to The seal integrity of the sterile bag containing the kits may be compromised.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The seal integrity of the sterile bag containing the kits may be compromised.
Recommended Action
Per FDA guidance
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 Strykerortho6807@stericycle.com 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 Stan.dube@stryker.com; your local Sales Office or the Stryker Sales Representative for assistance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026