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LinkSymphoKnee recallZ-1373-2025 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Feb 14, 2025

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

A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

FDA root cause category: Labeling Change Control

What the company is doing

On February 21, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the Customer/User: 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recall details

Recall number
Z-1373-2025
Status
Open, Classified
Initiated by the company
Feb 14, 2025
Posted by the FDA
Mar 17, 2025
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
52 units
Product code
JWH
FDA submissions
K202924
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.

Product description

Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

Code information (models, lots, serial numbers)

Product Code: 880-601/12; UDI-DI: 04026575443932; Lot Numbers: 1943274, 1943276, 2049172, 2049173, 2049175.

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 96386).

Sources and updates

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