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LinkSymphoKnee recallZ-2067-2023 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Dec 23, 2022

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 Waldemar Link GmbH & Co. KG (Mfg Site) 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

Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

FDA root cause category: Component change control

What the company is doing

LinkBio Corporation issued A Product Advisory Notice to consignees holding field inventory on 18-May-2023. The product is provided to the surgeon directly by the representative of the Distributor. Letter states reason for recall, health risk and action to take: Please ensure the surgical team is made aware of this issue before using one of the affected augments. While there is no safety impact due to this issue, there could be some confusion during assembly if the issue is not known in advance. No additional action is required by users beyond reinserting the screw in the correct orientation, and no product return is required at this time. Please contact your LinkBio Sales or Customer Service representative or the contact for any questions: Jennifer Lubrecht Senior Director, Quality Management LinkBio Corporation 69 King Street Dover, NJ 07801 Mobile: +1 862.477.0370 Email: [email protected]

Recall details

Recall number
Z-2067-2023
Status
Open, Classified
Initiated by the company
Dec 23, 2022
Posted by the FDA
Jul 3, 2023
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
20 units
Product code
JWH
FDA submissions
K202924
Distribution
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.

Product description

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21

Code information (models, lots, serial numbers)

UDI-DI: 04026575257393 Lot Number: 2123233

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

116 devices cleared under K202924 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 92496).

Sources and updates

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