PlainRecalls

Waldemar Link GmbH & Co. KG (Mfg Site)

34 recalls on record · Latest: Mar 18, 2026

Waldemar Link GmbH & Co. KG (Mfg Site) Recall Insight

Waldemar Link GmbH & Co. KG (Mfg Site) appears on 34 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.041% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 34 entries, severity tagging shows 0 critical, 34 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 33 of 34 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (34). The date window on this page runs from Jan 23, 2019 to Mar 18, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 18, 2026

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

FDA Devices Moderate Mar 18, 2026

Endo-Model Replacement Plateau; Item Number: 15-8030/12;

FDA Devices Moderate Mar 18, 2026

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

FDA Devices Moderate Mar 18, 2026

Endo-Model Replacement Plateau; Item Number: 15-8521/15;

FDA Devices Moderate Mar 18, 2026

Endo-Model Replacement Plateau; Item Number: 15-0027/15;

FDA Devices Moderate Aug 20, 2025

Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

FDA Devices Moderate May 7, 2025

Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cement…

FDA Devices Moderate May 7, 2025

Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md…

FDA Devices Moderate May 7, 2025

Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented …

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

FDA Devices Moderate Jan 1, 2025

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/…

FDA Devices Moderate Jul 24, 2024

Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/…

FDA Devices Moderate Mar 20, 2024

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

FDA Devices Moderate Mar 20, 2024

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

FDA Devices Moderate Mar 20, 2024

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

FDA Devices Moderate Mar 13, 2024

Embrace Drill Tower, Wedged (25mm)

FDA Devices Moderate Mar 6, 2024

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defec…

FDA Devices Moderate Jan 24, 2024

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code:…

FDA Devices Moderate Oct 4, 2023

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

FDA Devices Moderate Sep 6, 2023

Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthro…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip j…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip j…

FDA Devices Moderate Aug 16, 2023

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip…

FDA Devices Moderate Jul 5, 2023

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

FDA Devices Moderate Jul 20, 2022

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

FDA Devices Moderate Jul 20, 2022

Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic pros…

FDA Devices Moderate Jan 23, 2019

LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Us…

FDA Devices Moderate Jan 23, 2019

BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds