FDA recall record · openFDA
Waldemar Link GmbH & Co. KG (Mfg Site)
51 FDA recalls on record (2023–2026) — 51 device. 51 still ongoing.
0
Class I (most serious)
51
Class II
0
Class III
51
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudi 13
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Pote 12
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of t 4
The device was delivered with a preassembled Femoral Augment screw that was missing its thread. 4
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label 3
Recalls
Endo-Model Replacement Plateau; Item Number: 15-0027/11; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-8030/12; Class II 2026-01-12 Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-8521/15; Class II 2026-01-12 Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; Class II 2026-02-11 Endo-Model Replacement Plateau; Item Number: 15-0027/15; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-2835/12; Class II 2026-01-12 Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; Class II 2026-02-11 Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-2836/11; Class II 2026-01-12 Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-8521/09; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-8521/11; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-0027/12; Class II 2026-01-12 Endo-Model Replacement Plateau; Item Number: 15-0027/16; Class II 2026-01-12 Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) Class II 2025-04-03 Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880- Class II 2025-04-03 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11 Class II 2025-02-14 Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. Class II 2025-07-15 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13 Class II 2025-02-14 Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88 Class II 2025-04-03 Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. Class II 2025-07-15 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12 Class II 2025-02-14 Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compo Class II 2025-11-10 LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/ Class II 2025-07-31 L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) Class II 2025-04-03 LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting Class II 2024-01-22 SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Class II 2024-02-06 Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Compone Class II 2024-05-22 SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Class II 2024-02-06 Embrace Drill Tower, Wedged (25mm) Class II 2024-01-29 SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Class II 2024-02-06 LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Class II 2024-12-05 SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Class II 2024-02-06 Embrace Drill Tower, Standard/Lateral (25mm) Class II 2024-01-29 Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-281 Class II 2024-05-22 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, frac Class II 2023-07-03 Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthropla Class II 2023-11-30 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla Class II 2023-07-26 MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclina Class II 2023-07-14 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, frac Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fr Class II 2023-07-03
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.