Z-1810-2026Class II

LinkBio CORE Workstation, a component of the CORE Shoulder System

Name: Z-1810-2026 LinkBio CORE Workstation, a component of the CORE Shoulder System
Creator: Linkbio Corp.
Published: 2026-03-12
License: https://open.fda.gov/license/

LinkBio Corp. / initiated 2026-03-12 / Open, Classified

FDA source

Linkbio Corp. began a recall of LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136 on 2026-03-12. FDA classified it as Class II and gives the reason as "The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1810-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-12
Posted: 2026-04-10
Recalling firm: LinkBio Corp.
Product: LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Product code: QHE Shoulder Arthroplasty Implantation System
Reason for recall: The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
FDA 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 in commerce: 5 units
Distribution: US Nationwide distribution in the state of Alabama, Florida, and Kansas.
Product codes and lots: Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1810-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1810-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-10

Product code QHE

K241470Class IICORE Shoulder SystemLinkBio Corp. / cleared 2025-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)