Waldemar Link GmbH & Co. KG recalls
21 official recalls and safety alerts involving Waldemar Link GmbH & Co. KG since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Waldemar Link GmbH & Co. KG or the relevant agency.
- 2026-08-19
USWaldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be…
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.Official notice →- 2026-04-01
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are…
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH,…Official notice → - 2026-03-18
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice → - 2025-12-17
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee…
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US distribution to states of: AL, GA, and TX.Official notice → - 2025-09-17
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the…Official notice → - 2025-08-20
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Inconsistent size terminology and color coding used on labeling
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS,…Official notice → - 2025-05-07
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3)…
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL,…Official notice → - 2025-03-26
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA,…Official notice → - 2025-01-01
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,…
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, FL.Official notice → - 2024-10-02
- US
Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break…
FDA · DeviceWaldemar Link GmbH & Co. KG (Corp. Hq.)US Nationwide distribution in the states of FL, KS, MI, NJ, VA.Official notice → - 2024-07-24
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm…
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil…Official notice → - 2024-03-20
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN,…Official notice → - 2024-03-13
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm)
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL and LA.Official notice → - 2024-03-06
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting…
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the…Official notice → - 2024-01-24
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee…
Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to…
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the state of NH.Official notice → - 2023-10-04
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees…
Product is labeled with incorrect offset.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic distribution to AL, NJ, NV.Official notice → - 2023-09-06
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis…
A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a…
- 2023-08-16
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases,…
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this…
- 2023-07-12
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and…
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.Official notice → - 2023-07-05
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
The firm discovered through customer complaints that device segments may not meet specifications.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia,…Official notice → - 2022-07-20
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN,…Official notice →