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U.S. Department of Health and Human Services

Class 2 Device Recall Nextra

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  Class 2 Device Recall Nextra see related information
Date Initiated by Firm February 10, 2022
Create Date April 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-0913-2022
Recall Event ID 89764
510(K)Number K110445  
Product Classification Screw, fixation, bone - Product Code HWC
Product Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut
SKU: NX-3532K-SC
Orthopedic surgical instrument
Code Information Lot Number: 168125017B UDI: 00817701020059
Recalling Firm/
Manufacturer		 Nextremity Solutions
1195 Polk Dr
Warsaw IN 46582-8602
For Additional Information Contact SAME
574-3762062
Manufacturer Reason
for Recall		 Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Nextremity Solutions issued Urgent Medical Device Recall letter on 2/10/22 via mail and email to Distributors and Risk Mangers. Nextremity Solutions products with the referenced part and lot number should not be used and should be quarantined and returned to Zimmer Biomet for return to Nextremity Solutions. If you have affected product at your facility, locate and quarantine affected product in your inventory. Zimmer Biomet Sales representative will remove the affected product from your facility. Complete Medical Device Recall Return Response and send to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have affected products at your facility. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Or email to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 89 units
Distribution Distribution US Nationwide, Japan, and the Netherlands
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = NEXTREMITY SOLUTIONS, LLC
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