Recall Z-1534-2023— Linkbio Corp.

Name: FDA recall Z-1534-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-21

Class II · Ongoing

Class II FDA medical device recall by Linkbio Corp., initiated 2023-03-21. It names one FDA 510(k) clearance: K954186. Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11. 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.

Recalling firm: Linkbio Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-21
Firm location: Rockaway, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K954186 — SLED UNICOMPARTMENT KNEE SYSTEMLink America, Inc.·cleared 1996-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.