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U.S. Department of Health and Human Services

Class 2 Device Recall Endotrig, Endotrac and Endintrack Blade Kits

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  Class 2 Device Recall Endotrig, Endotrac and Endintrack Blade Kits see related information
Date Initiated by Firm July 25, 2019
Create Date August 28, 2019
Recall Status1 Terminated 3 on September 24, 2020
Recall Number Z-2418-2019
Recall Event ID 83423
510(K)Number K940230  
Product Classification Arthroscope - Product Code HRX
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.
Code Information Lot Numbers 01403, 01466, 01483
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Elizabeth Beato
201-831-5838
Manufacturer Reason
for Recall		 The seal integrity of the sterile bag containing the kits may be compromised.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 2248
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = INSTRATEK, INC.
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