Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Regulatory Profile

Waldemar Link GmbH & Co. KG (Mfg Site) appears in FDA public data with 65 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2934-2026, Class II) was initiated on July 6, 2026.

Summary

Total Recalls
65
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2934-2026Class IIEndo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item NumJuly 6, 2026
Z-1652-2026Class IIEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;February 11, 2026
Z-1651-2026Class IIEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;February 11, 2026
Z-1513-2026Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;January 12, 2026
Z-1518-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-8521/09;January 12, 2026
Z-1516-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-2836/11;January 12, 2026
Z-1523-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-0027/16;January 12, 2026
Z-1521-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-0027/11;January 12, 2026
Z-1512-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-0027/15;January 12, 2026
Z-1520-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-8521/15;January 12, 2026
Z-1515-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-2835/12;January 12, 2026
Z-1517-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-8030/12;January 12, 2026
Z-1522-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-0027/12;January 12, 2026
Z-1519-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-8521/11;January 12, 2026
Z-1514-2026Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;January 12, 2026
Z-1511-2026Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;January 12, 2026
Z-0890-2026Class IIEndo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, TapNovember 10, 2025
Z-2541-2025Class IILinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. July 31, 2025
Z-2288-2025Class IIProsthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.July 15, 2025
Z-2289-2025Class IIPlastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.July 15, 2025