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Waldemar Link GmbH & Co. KG (Mfg Site)

58 FDA 510(k) clearances · Recalling firm

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◉ Watch Waldemar Link GmbH & Co. KG (Mfg Site)

RecordFirmDate
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge recall (Z-2934-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-08-11
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; recall (Z-1651-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-27
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; recall (Z-1652-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-27
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; recall (Z-1511-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/15; recall (Z-1512-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; recall (Z-1513-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; recall (Z-1514-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-2835/12; recall (Z-1515-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-2836/11; recall (Z-1516-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8030/12; recall (Z-1517-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8521/09; recall (Z-1518-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8521/11; recall (Z-1519-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-8521/15; recall (Z-1520-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/11; recall (Z-1521-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/12; recall (Z-1522-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo-Model Replacement Plateau; Item Number: 15-0027/16; recall (Z-1523-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2026-03-10
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 6 recall (Z-0890-2026)Waldemar Link GmbH & Co. KG (Mfg Site)2025-12-09
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented recall (Z-2541-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-09-08
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. recall (Z-2288-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-08-11
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. recall (Z-2289-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-08-11
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 recall (Z-1699-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310 recall (Z-1700-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/ recall (Z-1701-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz recall (Z-1702-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-04-30
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product C recall (Z-1372-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-03-17
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product C recall (Z-1373-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-03-17
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product C recall (Z-1374-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2025-03-17
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 recall (Z-0769-2025)Waldemar Link GmbH & Co. KG (Mfg Site)2024-12-26
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 1 recall (Z-2410-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-07-18
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tib recall (Z-2411-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-07-18
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented recall (Z-1296-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-03-14
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented recall (Z-1297-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-03-14
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented recall (Z-1298-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-03-14
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented recall (Z-1299-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-03-14
Embrace Drill Tower, Wedged (25mm) recall (Z-1257-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-03-06
Embrace Drill Tower, Standard/Lateral (25mm) recall (Z-1258-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-03-06
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for p recall (Z-1219-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-02-29
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as recall (Z-0749-2024)Waldemar Link GmbH & Co. KG (Mfg Site)2024-01-18
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, + recall (Z-2641-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-09-26
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary can recall (Z-2481-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-29
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mo recall (Z-2345-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with recall (Z-2346-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with recall (Z-2347-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with recall (Z-2348-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with recall (Z-2349-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mo recall (Z-2350-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with recall (Z-2351-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with recall (Z-2352-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with recall (Z-2353-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with recall (Z-2354-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with recall (Z-2355-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with recall (Z-2356-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-08-04
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5m recall (Z-2066-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-07-03
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5 recall (Z-2067-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-07-03
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right recall (Z-2046-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-06-30
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left recall (Z-2047-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-06-30
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right recall (Z-2048-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-06-30
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left recall (Z-2049-2023)Waldemar Link GmbH & Co. KG (Mfg Site)2023-06-30

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Every clearance here is in the API, with alerts when new ones post.