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Open, Classified

LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

FDA Recall Z-1810-2026 · Posted 2026-04-10

Recalling FirmLinkbio Corp.
Recall StatusOpen, Classified
Product CodeQHE
Date Initiated2026-03-12
Product Quantity5 units

Reason for Recall

The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of Alabama, Florida, and Kansas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241470CORE Shoulder SystemLinkBio Corp. · 2025-02-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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