Linkbio Corp.: Medical Device Recall in 2023 - (Recall #: Z-1528-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03

Product Classification:

Class II

Date Initiated: March 21, 2023

Date Posted: May 10, 2023

Recall Number: Z-1528-2023

Event ID: 92088

Reason for Recall:

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

Status: Ongoing

Product Quantity: 15 units

Code Information:

UDI-DI: 04026575044078 All lot numbers within the labeled expiration date

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated