Recall Register

Food, drugs, devices › Firms

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA recalling firm · 22 enforcement events · 65 product records · 2018–2026 · N/A

Waldemar Link GmbH & Co. KG (Mfg Site) has 22 FDA enforcement events on this register (65 product records) between 2018 and 2026: 22 device; the busiest year was 2024 with 5.

0% of its events are Class I; the most common class is Class II (22). 20 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
6 Jul 2026Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16DeviceClass II1Ongoing
11 Feb 2026Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;DeviceClass II2Ongoing
12 Jan 2026Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;DeviceClass II13Ongoing
10 Nov 2025Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.DeviceClass II1Ongoing
31 Jul 2025LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50DeviceClass II1Ongoing
15 Jul 2025Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.DeviceClass II2Ongoing
3 Apr 2025Distal 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 sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8)…DeviceClass II4Ongoing
14 Feb 2025Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11DeviceClass II3Ongoing
5 Dec 2024LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as…DeviceClass II1Ongoing
22 May 2024Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12,…DeviceClass II2Ongoing
6 Feb 2024SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cementedDeviceClass II4Ongoing
29 Jan 2024Embrace Drill Tower, Wedged (25mm)DeviceClass II2Ongoing
22 Jan 2024LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12DeviceClass II1Ongoing
30 Nov 2023Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05DeviceClass II1Ongoing
26 Jul 2023Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01DeviceClass II1Ongoing
14 Jul 2023MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees InclinationDeviceClass II1Ongoing
3 Jul 2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00DeviceClass II12Ongoing
23 Dec 2022LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11DeviceClass II2Ongoing
24 May 2022Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.DeviceClass II4Ongoing
18 Mar 2021LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, RightDeviceClass II4Ongoing
7 Dec 2018LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or…DeviceClass II1Terminated
4 Dec 2018BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.DeviceClass II2Terminated

By type and class

Device22
Class II22

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for Waldemar Link GmbH & Co. KG (Mfg Site) by year initiated.

Questions and answers

How many FDA recalls has Waldemar Link GmbH & Co. KG (Mfg Site) had?

22 enforcement events (65 product records) on this register, 2018–2026: 22 device.

Are any Waldemar Link GmbH & Co. KG (Mfg Site) recalls ongoing?

20 events are listed as ongoing in the current openFDA export.

What class are Waldemar Link GmbH & Co. KG (Mfg Site) recalls?

22 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.