LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
FDA device recall Z-1810-2026 · posted 2026-04-10 · Open, Classified
Recall details
- Recalling firm
- Linkbio Corp.
- Reason for recall
- The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- QHE
- Quantity affected
- 5 units
- Distribution
- US Nationwide distribution in the state of Alabama, Florida, and Kansas.
- Date initiated
- 2026-03-12
- Date posted
- 2026-04-10
- Location
- Rockaway, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORE Shoulder System (K241470) | LinkBio Corp. | 2025-02-20 |