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U.S. Department of Health and Human Services

Class 2 Device Recall Nextra Hammertoe Correction System

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  Class 2 Device Recall Nextra Hammertoe Correction System see related information
Date Initiated by Firm February 12, 2020
Date Posted February 24, 2020
Recall Status1 Terminated 3 on December 17, 2020
Recall Number Z-1458-2020
Recall Event ID 84924
510(K)Number K110445  
Product Classification Screw, fixation, bone - Product Code HWC
Product Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.
REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Code Information Lot Number: 168117318B UDI: 00817701020011
Recalling Firm/
Manufacturer		 Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information Contact SAME
732-683-9305
Manufacturer Reason
for Recall		 Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
FDA Determined
Cause 2		 Under Investigation by firm
Action Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number.
Quantity in Commerce 190 units
Distribution International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
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 = HWC and Original Applicant = NEXTREMITY SOLUTIONS, LLC
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