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Open, Classified

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

FDA Recall Z-1380-2022 · Posted None

Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2022-05-24
Product Quantity3785

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coatingWaldemar Link GmbH & Co. KG · 2021-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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