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.
FDA Recall Z-2418-2019 · Posted None
Advertisement
Recalling FirmStryker GmbH
Recall StatusTerminated
Product CodeHRX
Date Initiated2019-07-25
Date Terminated2020-09-24
Product Quantity2248
Reason for Recall
The seal integrity of the sterile bag containing the kits may be compromised.
Firm 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.
Root Cause
Packaging
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement