FDA-Device2026-04-22Class IIPROCESSING DEFECT
LinkBio CORE Workstation recalled for incorrect Planning Date display
What this means
The LinkBio CORE Workstation, part of the CORE Shoulder System, may show an incorrect Planning Date when you view cases in the Start Case menu. This could lead to confusion about case timing. Five units are affected across Alabama, Florida, and Kansas.
- Verify the Planning Date displayed on your CORE Workstation against your records before starting any case
- Contact LinkBio Corp. for instructions on updating or correcting the date display
- If you own unit serial number matching product code 87-9136, contact your LinkBio representative
The agency's original wording
Hazard
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Alabama, Florida, and Kansas.
Affected count
5 units
Manufactured in
101 Round Hill Dr Ste 7, N/A, Rockaway, NJ, United States
Products
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2026Want us to check the next one for you?
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