FDA Medical Device Recalls (openFDA)
Linkbio Corp.: LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
- Recall number
- Z-1810-2026
- Recalling firm
- Linkbio Corp.
- Product
- LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
- Status
- Open, Classified
- Initiated
- 2026-03-12
- Posted
- 2026-04-10
- Terminated
- not on file
- Reason
- The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
- 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
- 5 units
- Distribution
- US Nationwide distribution in the state of Alabama, Florida, and Kansas.
- Lot, serial or model codes
- Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.
- 510(k) numbers
- ["K241470"]
- PMA numbers
- not on file
- Product code
- QHE
- Firm FEI
- 3006721341
- Firm city
- Rockaway
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28