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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HWC
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