Rockaway, NJ, United States

Linkbio Corp. recalls

3 recalls recorded since 2018, most recently on 12 March 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls3

Ongoing (FDA)3

Terminated or completed0

Class I (FDA)0

Recall started: 12 March 2026
Reason: The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Distribution: US Nationwide distribution in the state of Alabama, Florida, and Kansas.
Initiated: Voluntary: Firm initiated
Recall number: Z-1810-2026

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

Recall started: 25 April 2023
Reason: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Distribution: US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
Initiated: Voluntary: Firm initiated
Recall number: Z-1674-2023

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

Recall started: 21 March 2023
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Distribution: NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1523-2023, Z-1550-2023, Z-1517-2023, Z-1540-2023, Z-1554-2023, Z-1521-2023, Z-1541-2023, Z-1539-2023, Z-1508-2023, Z-1529-2023, Z-1526-2023, Z-1546-2023 and 36 more

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
and 40 more product lines

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.