Waldemar Link GmbH & Co. KG (Mfg Site) recalls
Every recall we track for Waldemar Link GmbH & Co. KG (Mfg Site) — 65 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Waldemar Link GmbH & Co. KG (Mfg Site) peaked in 2023 (15); 65 since 2017.
All FDA recall records for Waldemar Link GmbH & Co. KG (Mfg Site) since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 1 | 2 | 0 | 3 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 3 | 1 | 4 |
| 2022 | 0 | 5 | 0 | 1 | 6 |
| 2023 | 0 | 13 | 2 | 0 | 15 |
| 2024 | 0 | 2 | 8 | 0 | 10 |
| 2025 | 0 | 2 | 8 | 1 | 11 |
| 2026 (to date) | 0 | 1 | 4 | 11 | 16 |
Most common reasons for Waldemar Link GmbH & Co. KG (Mfg Site) recalls
What to do if you have a recalled Waldemar Link GmbH & Co. KG (Mfg Site) product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Waldemar Link GmbH & Co. KG (Mfg Site) recalls
22 shown- Lower riskMedical device
Waldemar 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
Waldemar Link recalls Endo-Model replacement sets with incorrect Pure Hinge plateau that may require surgery changes and increase implant wear risk. Affected items have specific item numbers and lot codes.
Waldemar LinkJul 6, 2026 - Lower riskMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Waldemar Link recalls Embrace Drill Tower Wedged (25mm) due to mixed-up article numbers in surgical technique documentation, which could lead to incorrect instrument usage during procedures.
Waldem: EmbraceFeb 11, 2026 - UnratedMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Waldemar Link recalls Endo-Model Replacement Plateau (item 15-002:11) due to potential screw detachment from fracture. Affected units have specific serial numbers.
Waldemar LinkJan 12, 2026 - Lower riskMedical device
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
Waldemar Link recalls specific knee fusion nails due to a preassembled locking screw inserted from the wrong side, potentially causing improper joint alignment during surgery.
Waldemar LinkNov 10, 2025 - Use cautionMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number:
Waldemar Link recalls some LinkSymphoKnee Tibial Components with uncoated security screws. These components may not hold securely, risking joint instability. Affected units have specific serial numbers and REF numbers.
Waldemar LinkJul 31, 2025 - Lower riskMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Waldemar Link recalls Prosthesis Head B (28mm, 7mm neck) due to inconsistent size labeling. Affected units have specific serial numbers and item numbers. Consumers should check their product details to determine if recalled.
Waldemar LinkJul 15, 2025 - Lower riskMedical device
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),
Waldemar Link recalls Posterior Femoral Augment implants with missing thread screws. These devices may not function properly during surgery. Affected items have specific item numbers and sizes.
Waldemar LinkApr 3, 2025 - Lower riskMedical device
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
Waldemar Link recalls specific modular stem implants due to incorrect outer carton label GTIN causing confusion with other products. Affected units have Product Code 880-601/11 and Lot Numbers 1943294-1943297, 2049174.
Waldemar LinkFeb 14, 2025 - Lower riskMedical device
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,
Waldemar Link recalls specific neck segments due to label error showing size XXL instead of standard. All other details correct. Affected patients should verify product details to avoid incorrect use.
Waldemar LinkDec 5, 2024 - Use cautionMedical device
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:
Waldemar Link recalls Endo Model SL Tibial Components with blind screws that cannot be loosened during surgery, potentially causing prolonged procedures. Affected units manufactured since June 1, 2022.
Waldemar LinkMay 22, 2024 - Lower riskMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Waldemar Link recalls SPII Model Lubinus Long Stem Prosthesis XL Neck cemented implants due to potential misinterpretation of carton labels during surgery. Affected units have specific product codes.
Waldemar LinkFeb 6, 2024 - Lower riskMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm)
Waldemar Link recalls Embrace Drill Tower Wedged (25mm) surgical instruments due to mixed-up type descriptions in the product manual, potentially causing confusion in surgical procedures.
Waldem: EmbraceJan 29, 2024 - Lower riskMedical device
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
Waldemar Link recalls specific E-Poly Liner models due to mislabeled packaging that could delay surgery for patients with hip issues. Affected units have item numbers 184-280/12 and lot numbers 2334253, 2325426.
Waldem:LinkJan 22, 2024 - Lower riskMedical device
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
Waldemar Link recalls a knee surgery guide due to mislabeled size causing potential inadequate bone removal during surgery. Affected units have specific product codes and serial numbers.
Waldem: LinkNov 30, 2023 - Use cautionMedical device
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
Waldemar Link recalls OptiStem Rasp Handles used in knee surgery due to potential crack causing surgery delays or modifications. Affected items have specific lot codes and item numbers.
Waldemar LinkJul 26, 2023 - Lower riskMedical device
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
Waldemar Link recalls MobileLink Acetabular Cup System with incorrect offset labeling. This may affect surgical implants for hip replacements. Affected units have specific UDI-DI and lot numbers.
Waldemar LinkJul 14, 2023 - Use cautionMedical device
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,
Waldemar Link recalls LINK MP Monoblock Hip Stem (Size 17) for potential increased force needed during removal, possibly prolonging surgery. Affected patients with mobility issues may need surgical adjustments.
Waldemar LinkJul 3, 2023 - Use cautionMedical device
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
Recall of LinkSymphoKnee Distal Femoral Augment (Size 7-8) due to risk of improper screw insertion causing potential complications. Affected units include specific product codes and lot numbers.
Waldem:LinkDec 23, 2022 - Use cautionMedical device
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
Waldemar Link recalls specific orthopedic prosthesis models due to risk of blind screws that cannot be loosened during surgery, potentially prolonging procedures. Affected models include Small (W 16-2817/32), Medium (W 16-2817/35), and Large (W 16-2817/37).
Waldemar LinkMay 24, 2022 - Lower riskMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Waldemar Link recalls left knee prosthesis segment size 3 due to potential failure to meet specifications. Affected units include specific model and serial numbers. Consumers should contact the company for details.
Waldemar LinkMar 18, 2021 - Use cautionMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference
Waldemar Link recalls certain LINK STEM prosthesis models due to potential incorrect neck fit causing improper joint alignment. Affected units have specific lot numbers and sizes.
Waldemar LinkDec 7, 2018 - Lower riskMedical device
Waldemar Link GmbH & Co. KG (Mfg Site) recalls BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated
Waldemar Link recalls BiMobile UHMWPE Liner (ID-28mm/OD-54mm, Ref 184-260/04) due to potential incorrect part numbers in labeling that could lead to patient record errors. Affected patients should contact the manufacturer for guidance.
Waldemar LinkDec 4, 2018
Waldemar Link GmbH & Co. KG (Mfg Site) recall questions
How many recalls has Waldemar Link GmbH & Co. KG (Mfg Site) had?
65 recalls from Waldemar Link GmbH & Co. KG (Mfg Site) are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Waldemar Link GmbH & Co. KG (Mfg Site) recall?
Waldemar 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, dated Jul 6, 2026. Every Waldemar Link GmbH & Co. KG (Mfg Site) recall is listed on this page, newest first.
Why are Waldemar Link GmbH & Co. KG (Mfg Site) products recalled?
The most common reasons on record: Inconsistent size terminology and color coding used on labeling (2).
What should I do if I have a recalled Waldemar Link GmbH & Co. KG (Mfg Site) product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Waldemar Link GmbH & Co. KG (Mfg Site) recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.