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Endo-Model SL Knee Prosthesis System recallZ-2411-2024 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated May 22, 2024

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

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDA root cause category: Process design

What the company is doing

LinkBio issue Urgent Medical Device Correction letter to Distributors via email on June 10, 2024. Letter states reason for recall, health risk and action to take: Please take note of the attached modified Surgical Technique for cementing the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, provided in Appendix A of this notice. 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 apply the provided cementing surgical technique for the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, in case the blind screws are unable to be removed. Please contact LinkBio at 973-625-1333 or [email protected] for any questions

Recall details

Recall number
Z-2411-2024
Status
Open, Classified
Initiated by the company
May 22, 2024
Posted by the FDA
Jul 18, 2024
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
114 units US; 2351 units OUS
Product code
JWH
FDA submissions
K212742, K143179, K151008
Distribution
Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam

Product description

Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm

Code information (models, lots, serial numbers)

Product UDI-DI 16-2817/02 04026575359202; 16-2817/05 04026575359219; 16-2817/07 04026575359226; 16-2817/32 04026575370870; 16-2817/35 04026575370887; 16-2817/37 04026575370894. All product lots manufactured since 01-Jun-2022.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

62 devices cleared under K212742, K143179, K151008 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 94814).

Sources and updates

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