Class II U.S. Food and Drug Administration

LinkBio recall: The CORE Workstation may display an incorrect "Planning Date " when viewing

Recall published 6 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1810-2026
Published
April 22, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Linkbio Corp.
Product type
Medical devices
Units affected
5 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.

Products covered by this recall

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

What to do about Device

Linkbio Corp. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Linkbio Corp. — 101 Round Hill Dr Ste 7, Rockaway, NJ, 07866-1214

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Linkbio Corp. medical devices recalled?

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

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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