Home / Recalls / Waldemar Link GmbH & Co. KG (Mfg Site) / Z-1379-2022

Z-1379-2022 Class II Ongoing

Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt

Recall Details

Product Type
Devices
Report Date
July 20, 2022
Initiation Date
May 24, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3785

Product Description

Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07

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.

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

Code Information

UDI-DI: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 201002/1683 211025/1543 210202/0275 210302/0308 210314/1872 201002/1687

Other recalls by Waldemar Link GmbH & Co. KG (Mfg Site)

  • Z-1652-2026 Class II — Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; (February 11, 2026)
  • Z-1651-2026 Class II — Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; (February 11, 2026)
  • Z-1518-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-8521/09; (January 12, 2026)
  • Z-1521-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-0027/11; (January 12, 2026)
  • Z-1516-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-2836/11; (January 12, 2026)
  • Z-1513-2026 Class II — Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; (January 12, 2026)
  • Z-1520-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-8521/15; (January 12, 2026)
  • Z-1522-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-0027/12; (January 12, 2026)
  • Z-1512-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-0027/15; (January 12, 2026)
  • Z-1523-2026 Class II — Endo-Model Replacement Plateau; Item Number: 15-0027/16; (January 12, 2026)