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U.S. Department of Health and Human Services

Class 2 Device Recall Nextremty Solutions

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  Class 2 Device Recall Nextremty Solutions see related information
Date Initiated by Firm March 26, 2021
Create Date April 27, 2021
Recall Status1 Terminated 3 on November 10, 2021
Recall Number Z-1501-2021
Recall Event ID 87665
Product Classification Screw, fixation, bone - Product Code HWC
Product InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Code Information Lot Number: 168B29619B UDI: 00817701020875
Recalling Firm/
Manufacturer		 Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information Contact SAME
732-683-9305
Manufacturer Reason
for Recall		 Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
FDA Determined
Cause 2		 Under Investigation by firm
Action Nextremity Solutions issued Urgent Medical Device Recall Letter to Distributors and Risk Managers on March 26,2021 stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 - Medical Device Recall Return Response and send to Corporate Quality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit facility's documentation. 5. 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. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 123 units
Distribution AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
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.
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