Recall Z-1810-2026 ยท QHE Shoulder Arthroplasty Implantation System
Linkbio Corp.
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
| Date | Apr 10, 2026 (initiated Mar 12, 2026) |
| Status | Open, Classified |
| Reason | The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the state of Alabama, Florida, and Kansas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241470 | CORE Shoulder System LinkBio Corp., Feb 20, 2025 |