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LinkSymphoKnee recallZ-1674-2023 · Linkbio Corp. · initiated Apr 25, 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

Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

FDA root cause category: Under Investigation by firm

What the company is doing

LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

Recall details

Recall number
Z-1674-2023
Status
Open, Classified
Initiated by the company
Apr 25, 2023
Posted by the FDA
Jun 1, 2023
Recalling firm
Linkbio Corp.
Quantity
11 units
Product code
JWH
FDA submissions
K202924
Distribution
US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX

Product description

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

Code information (models, lots, serial numbers)

UDI-DI : 04026575258123 Lot Number: 1910003

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.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page