Waldemar Link GmbH & Co. KG (Mfg Site)
Complete recall history across all FDA and CPSC categories — 64 total recalls
Waldemar Link GmbH & Co. KG (Mfg Site) appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (64)
FDA medical device enforcement actions by Waldemar Link GmbH & Co. KG (Mfg Site). Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 11, 2026 | Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has... | Class II |
| Feb 11, 2026 | Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/16; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/12; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/11; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/09; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-2836/11; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-2835/12; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/15; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/15; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8030/12; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/11; | The potential for an implant with a plateau screw where the bushing could det... | Class II |
| Nov 10, 2025 | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right,... | The device has been delivered with a preassembled locking screw that had been... | Class II |
| Jul 31, 2025 | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/Ti... | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with tw... | Class II |
| Jul 15, 2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. | Inconsistent size terminology and color coding used on labeling | Class II |
| Jul 15, 2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. | Inconsistent size terminology and color coding used on labeling | Class II |
| Apr 3, 2025 | L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm),... | The device was delivered with a preassembled Femoral Augment screw that was m... | Class II |
| Apr 3, 2025 | Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (... | The device was delivered with a preassembled Femoral Augment screw that was m... | Class II |
| Apr 3, 2025 | Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 8... | The device was delivered with a preassembled Femoral Augment screw that was m... | Class II |
| Apr 3, 2025 | Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm)... | The device was delivered with a preassembled Femoral Augment screw that was m... | Class II |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12... | A problem was discovered during the scanning process of the outer carton labe... | Class II |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13... | A problem was discovered during the scanning process of the outer carton labe... | Class II |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 1... | A problem was discovered during the scanning process of the outer carton labe... | Class II |
| Dec 5, 2024 | LINK MP Reconstruction System Neck Segment (with suture holes, standard, unc... | Error on the main label and the patient label. The labels indicate a size XXL... | Class II |
| May 22, 2024 | Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes... | Blind screws of the modular tibial component cannot be loosened intraoperativ... | Class II |
| May 22, 2024 | Endo Model SL Tibial Components 16-2817/02 Tibial Component... | Blind screws of the modular tibial component cannot be loosened intraoperativ... | Class II |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is ... | Class II |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is ... | Class II |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is ... | Class II |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is ... | Class II |
| Jan 29, 2024 | Embrace Drill Tower, Standard/Lateral (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Ar... | Class II |
| Jan 29, 2024 | Embrace Drill Tower, Wedged (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Ar... | Class II |
| Jan 22, 2024 | LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert ... | Class II |
| Nov 30, 2023 | Link Patella Glide Resection Guide- For the implantation of the Endo-Model Kn... | Mislabeled: Angle and height of the device marked as L(large) corresponds to ... | Class II |
| Jul 26, 2023 | Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral ... | A crack in the weld of the rasp handle may lead to a fracture of the frontal ... | Class II |
| Jul 14, 2023 | MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Ins... | Product is labeled with incorrect offset. | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip ste... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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