Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Linkbio Corp. with 50 device recalls and 2 510(k) clearances. The most recent is a device recall dated Mar 12, 2026: LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 12, 2026 | LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.Class II · The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. | Device recalls |
| Feb 20, 2025 | CORE Shoulder SystemK241470 · QHE | 510(k) clearances |
| Apr 25, 2023 | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision tClass II · Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (La | Device recalls |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13Class II · Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update | Device recalls |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11Class II · Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update | Device recalls |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07Class II · Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update | Device recalls |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46Class II · Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update | Device recalls |
| Mar 21, 2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15Class II · Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update | Device recalls |
| Mar 21, 2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11Class II · Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update | Device recalls |
| Oct 25, 2019 | Instruments for LINK MEGASYSTEM-C FamilyK190181 · KRO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
