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U.S. Department of Health and Human Services

Class 2 Device Recall TOPS Inserter

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 Class 2 Device Recall TOPS Insertersee related information
Date Initiated by FirmJuly 16, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2516-2025
Recall Event ID 97367
PMA NumberP220002 
Product Classification Prosthesis, posterior spinal elements - Product Code QWK
ProductTOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Code Information Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
FEI Number 3012401682
Recalling Firm/
Manufacturer		 PREMIA SPINE LTD
Giborey Israel 7
Ramat Poleg
Netanya Israel
Manufacturer Reason
for Recall		Potential for missing pins at tip of inserter.
FDA Determined
Cause 2		Process change control
ActionOn 07/16/2025, Premia Spine Ltd. notified Premia Spine Inc. via phone call. It was requested to quarantine any suspected reworked instruments that are at the warehouse and to initiate a field action and return the affected units of the TOPS Inserter that underwent rework. No customers (hospitals/physicians) were asked to quarantine or return units as all affected units were within Premia Spine's control, however one surgeon was notified, on about 07/31/2025, of the issue and was requested to review the surgical procedure, analyze relevant patient data, including x-ray, and perform additional actions if needed to confirm the pin has not remained in the patient's body.
Quantity in Commerce30 units
DistributionUS Nationwide distribution in the state of Connecticut.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = QWK
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