Linkbio Corp.: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07

Recall number

Z-1547-2023

Recalling firm

Linkbio Corp.

Product

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07

Status

Open, Classified

Initiated

2023-03-21

Posted

2023-05-04

Terminated

not on file

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

Root cause

Labeling design

Action

LinkBio issued Urgent Medical Device Correction letter on March 21, 2023 to US Distributors. Letter states reason for recall, health risk and action to take: Please take note of the amendment / reinforcement of the Surgical Technique and participate in future offering of product training on the updated technique. Two warnings have been added. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Attendance in future product training on the LINK SLED is required for continued use of the system. No action is required for devices which have already been implanted; continue with regular follow-up activities for patients who have received the LINK SLED knee system. All product lots of the above item numbers still within the labeled expiration date are in scope for this device correction. Waldemar Link GmbH & Co. KG is updating the surgical technique to incorporate the new warnings. The company will also be providing product training, through the LinkBio Medical Education team. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.

Quantity

3 units

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

Lot, serial or model codes

UDI-DI: 04026575429172 All lot numbers within the labeled expiration date

510(k) numbers

["K152431","K212742"]

PMA numbers

not on file

Product code

KRO

Firm FEI

3006721341

Firm city

Rockaway

Firm state

NJ

Firm country

not on file

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

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