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Unicondylar Sled Prosthesis recallZ-1537-2023 · Linkbio Corp. · initiated Mar 21, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Linkbio Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling design

What the company is doing

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 [email protected] for any questions.

Recall details

Recall number
Z-1537-2023
Status
Open, Classified
Initiated by the company
Mar 21, 2023
Posted by the FDA
May 4, 2023
Recalling firm
Linkbio Corp.
Quantity
14 units
Product code
HSX
FDA submissions
K954186
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

Product description

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14

Code information (models, lots, serial numbers)

UDI-DI: 04026575436712 All lot numbers within the labeled expiration date

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

31 devices cleared under K954186 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92088).

Sources and updates

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