Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Nextra Hammertoe Correction System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Nextra Hammertoe Correction Systemsee related information
Date Initiated by FirmFebruary 12, 2020
Date PostedFebruary 24, 2020
Recall Status1 Terminated 3 on December 17, 2020
Recall NumberZ-1458-2020
Recall Event ID 84924
510(K)NumberK110445 
Product Classification Screw, fixation, bone - Product Code HWC
ProductNextra 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
FEI Number 3009540749
Recalling Firm/
Manufacturer		 Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information ContactSAME
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
ActionNextremity 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 Commerce190 units
DistributionInternational distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
-
-