Recall Z-1810-2026
Linkbio Corp. · initiated March 12, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Codes / lots: Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.
Reason for recall
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
FDA-determined cause: Under Investigation by firm
Action taken
LinkBio 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.
Details
- Recall number
- Z-1810-2026
- Initiated
- March 12, 2026
- Posted by FDA
- April 10, 2026
- Product code
- QHE – Shoulder Arthroplasty Implantation System
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the state of Alabama, Florida, and Kansas.
- Recalling firm
- Linkbio Corp., Rockaway, NJ