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U.S. Department of Health and Human Services

Class 2 Device Recall Ankle Arthrodesis Nail

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  Class 2 Device Recall Ankle Arthrodesis Nail see related information
Date Initiated by Firm April 27, 2018
Create Date July 10, 2018
Recall Status1 Terminated 3 on May 21, 2020
Recall Number Z-2407-2018
Recall Event ID 80131
510(K)Number K003018  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Code Information GTIN: 04546540673398; Lot code: K078C7E 
Recalling Firm/
Manufacturer
Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Aminah Crawford
201-831-5272
Manufacturer Reason
for Recall
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
FDA Determined
Cause 2
Employee error
Action Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 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. 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. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 6. Branches/Agencies: Return all affected products available at your location to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 PR 1774317 Event 6020 7. Hospitals/Branches/Agencies: Complete and sign the enclosed Business Reply Form and fax to 1-888-230-2125 or to Email: strykerortho6020@stericycle.com
Distribution The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
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 = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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