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Endo-Model SL Knee Prosthesis System recallZ-1380-2022 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated May 24, 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

There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On May 24, 2022, the firm notified affected customers via Urgent Field Safety Notice email. Customers were provided a modified surgical technique providing information for the cementing technique for Tilastan proximal spacers to minimize the risk. No product return is required.

Recall details

Recall number
Z-1380-2022
Status
Open, Classified
Initiated by the company
May 24, 2022
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
3785
Product code
JWH
FDA submissions
K212742
Distribution
Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam

Product description

Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37

Code information (models, lots, serial numbers)

UDI-DI:  04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W;  Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741

Devices named in this recall

3 devices 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 K212742 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 90477).

Sources and updates

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