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U.S. Department of Health and Human Services

Class 2 Device Recall LinkBio CORE Workstation, a component of the CORE Shoulder System

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 Class 2 Device Recall LinkBio CORE Workstation, a component of the CORE Shoulder Systemsee related information
Date Initiated by FirmMarch 12, 2026
Date PostedApril 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1810-2026
Recall Event ID 98594
510(K)NumberK241470 
Product Classification Shoulder arthroplasty implantation system - Product Code QHE
ProductLinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Code Information Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.
FEI Number 3006721341
Recalling Firm/
Manufacturer		 Linkbio Corp.
101 Round Hill Dr Ste 7
Rockaway NJ 07866-1214
For Additional Information ContactJennifer Lubrecht
973-625-0766
Manufacturer Reason
for Recall		The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
FDA Determined
Cause 2		Under Investigation by firm
ActionLinkBio notified consignees on about 03/12/2026 via email. Consignees were instructed to take note of the potential inaccuracy of the "Planning Date," that no product was required to be returned, and to complete and return the Distributor Reply form. LinkBio Corp. is investigating the root cause of the time/date sync issue and will take appropriate action to ensure accurate dates are displayed for the user.
Quantity in Commerce5 units
DistributionUS Nationwide distribution in the state of Alabama, Florida, and Kansas.
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.
510(K) Database510(K)s with Product Code = QHE
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