Endo-Model SL Knee Prosthesis SystemRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Endo-Model SL Knee Prosthesis System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 6
We found 25 models of Endo-Model SL Knee Prosthesis System by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between May 10, 2022 and Aug 13, 2026 — classified as 38 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Endo-Model SL Knee Prosthesis System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1514-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1513-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 12, 2026Open, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1511-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 22, 2024Open, Classified
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Z-2411-2024 · Root cause: Process design · names 6 of these models · Recall details · FDA record ↗
- May 24, 2022Open, Classified
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.
Z-1380-2022 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗
- May 24, 2022Open, Classified
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.
Z-1379-2022 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗
Most reported Endo-Model SL Knee Prosthesis System problems
Device problems
- Detachment of Device or Device Component26
- Fracture9
- Activation Failure6
- Loosening of Implant Not Related to Bone-Ingrowth5
- Unstable4
- Osseointegration Problem3
- Nonstandard Device2
- Positioning Failure2
Patient problems
- Failure of Implant17
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information12
- Joint Laxity9
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Hyperextension1
Endo-Model SL Knee Prosthesis System models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Endo-Model SL Knee Prosthesis System 16-2817/02Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model SL Knee Prosthesis System 16-2817/05Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model SL Knee Prosthesis System 16-2817/07Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model SL Knee Prosthesis System 16-2817/32Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model SL Knee Prosthesis System 16-2817/35Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model SL Knee Prosthesis System 16-2817/37Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Endo-Model SL Knee Prosthesis System 16-2840/07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall2 reports
- Endo-Model SL Knee Prosthesis System 16-2855/21Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model SL Knee Prosthesis System 16-2857/21Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model SL Knee Prosthesis System 16-2849/25Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 reports
- Endo-Model SL Knee Prosthesis System 15-8523/44Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2 reports
- Endo-Model SL Knee Prosthesis System 16-2821/22Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2 reports
- Endo-Model SL Knee Prosthesis System 16-2841/02Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 16-2853/21Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 15-8524/58Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 15-8516/56Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 15-8515/55Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 15-8523/50Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 report
- Endo-Model SL Knee Prosthesis System 15-8523/61Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 15-8523/62Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 16-2821/21Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- Endo-Model SL Knee Prosthesis System 16-2825/22Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 report
- Endo-Model SL Knee Prosthesis System 16-2920/05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 report
Recent Endo-Model SL Knee Prosthesis System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Difficult or Delayed Separation
Notified that a revision to an connection component on an Endo SL was performed today with Dr. (b)(6), and there was difficulty in removing the connection component and there was damage to the femur, insert, bushings and the mechanism, with the screw almost completely worn down.The procedure was extended for approximately 30 minutes. The parts will be returned for the investigation when received. "[customer]".
Patient problems: Insufficient Information
MAUDE report 50233302 ↗InjuryJun 24, 2026Fracture
BREAKAGE OF THE CONNECTION COMPONENT [CUSTOMER].
Patient problems: Insufficient Information
MAUDE report 25606416 ↗InjuryMay 28, 2026Detachment of Device or Device Component
Wear and tear of the bushings and resulting luxation of the joint. "[customer]".
Patient problems: Insufficient Information
MAUDE report 25314500 ↗InjuryMay 6, 2026Detachment of Device or Device Component
A DFR COMPONENT WILL BE REVISED ON (B)(6) 2026 AS IT APPEARS TO HAVE FAILED BUSHINGS/INTERNAL COMPONENTS. THE PART WAS IMPLANTED ON (B)(6) 2019 [CUSTOMER].
Patient problems: Insufficient Information
MAUDE report 25092312 ↗InjuryApr 29, 2026Detachment of Device or Device Component
UNKNOWN EVENT DATE: NOTIFIED BY (B)(6) THAT A DFR COMPONENT WILL BE REVISED ON (B)(6) 2026 BY DR. (B)(6) AS IT APPEARS TO HAVE FAILED BUSHINGS/INTERNAL COMPONENTS. THE PART WAS IMPLANTED ON (B)(6) 2019 BY DR.(B)(6).
Patient problems: Joint Laxity
MAUDE report 25035972 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
NOTIFIED BY (B)(6) OF A REVISION TO A SPECIAL ACCESS ORDER WITH DR. (B)(6) BECAUSE OF AN INFECTED DISTAL FEMUR REQUIRING A WASHOUT AND EXCHANGE OF COMPONENTS. THE SURGEON STATED THAT IN HIS OPINION THE IMPLANT DID NOT CAUSE THE INFECTION. THE SURGEON BELIEVES THAT THE INFECTION IS DUE TO THE PATIENT BEING IMMUNOCOMPROMISED DUE TO CHEMOTHERAPY.
Patient problems: Medical device site infection
MAUDE report 24336335 ↗InjuryJan 15, 2026Fracture; Osseointegration Problem
COMPLETE FRACTURE OF THE STEM BODY.
Patient problems: Insufficient Information
MAUDE report 24078073 ↗MalfunctionJan 13, 2026Crack; Fracture
DURING IMPLANTATION IT WAS NOTICED THAT THE IMPLANT HAD BEEN DELIVERED WITH A PLATEAU SCREW WHOSE BUSHING HAD DETACHED FROM THE SCREW SHAFT DUE TO A LONGITUDINAL CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050694 ↗MalfunctionOct 2, 2025Nonstandard Device; Nonstandard Device
DIFFICULTIES WITH COUPLING, NOTICED MANUFACTURING DEFECT. [CUSTOMER].
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23197623 ↗InjurySep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
UNKNOWN EVENT DATE. NOTIFICATION FROM REPRESENTATIVE M. D. THAT THE DOCTOR WILL BE REVISING A CONPONENT PREVIOUSLY IMPLANTED ON (B)(6) 2023, BECAUSE OF DISASSOCIATION. HE WILL ONLY BE REPLACING THE HINGE AND THE BUSHINGS. REVISION WILL TAKE PLACE ON (B)(6) 2025. [CUSTOMER]
Patient problems: Insufficient Information
MAUDE report 22932054 ↗MalfunctionAug 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THERE IS A FOREIGN OBJECT IN THE SOCKET HEAD OF THE SCREW THAT PREVENTS THE SCREW FROM BEING USED. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882614 ↗InjuryApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT CAME IN FOR A CHECK-UP WITH PAIN. UNSTABLE KNEE JOINT. [CUSTOMER].
Patient problems: Pain
MAUDE report 21924098 ↗InjuryApr 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DISASSEMBLY FAILURE OF THE IMPLANT HINGE. [CUSTOMER].
Patient problems: Insufficient Information
MAUDE report 21823493 ↗InjuryApr 11, 2025Fracture; Fracture
- PATIENT CAME BECAUSE OF PAIN - AFTER X-RAY CONTROL, A CONE BREAK WAS FOUND. [CUSTOMER].
Patient problems: Pain
MAUDE report 21823492 ↗InjuryApr 11, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
IN (B)(6) 2024, THE PATIENT DEVELOPED ABNORMAL SOUND IN THE RIGHT KNEE JOINT WITHOUT OBVIOUS CAUSE, AND THEN HE WAS TREATED IN OUR HOSPITAL. IN (B)(6) 2024, THE IMAGING EXAMINATION SHOWED THE POSTOPERATIVE PERFORMANCE OF THE RIGHT KNEE JOINT. THERE WAS NO OBVIOUS PROSTHESIS FRACTURE, AND THE MEDIAL AND LATERAL GAPS OF THE RIGHT KNEE ARTIFICIAL JOINT WERE UNEQUAL. ON (B)(6) 2024, THE RIGHT KNEE ARTIFICIAL JOINT REVISION WAS PERFORMED, AND THE MEDIAL AND LATERAL FEMORAL CONDYLE GASKETS WERE FRACTURED AND DAMAGED. LINK SMALL FEMORAL CONDYLE AND SMALL CONNECTING SHAFT WERE REPLACED. THE PATIENT RECOVERED SMOOTHLY AFTER THE OPERATION AND WAS DISCHARGED ON (B)(6) 2024. [CUSTOMER].
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21823491 ↗
Other WALDEMAR LINK GmbH & Co. KG products
- Unicondylar Sled Prosthesis48 models · 12 reports · 48 recalls
- Endo-Model Modular Knee Prosthesis System64 models · 57 reports · 12 recalls
- LinkSymphoKnee117 models · 79 reports · 11 recalls
- LINK Instrument14 models · 8 reports · 12 recalls
- Endo-Model Standard Knee Prosthesis System15 models · 19 reports · 6 recalls
- LINK Embrace Shoulder System Line Extension2 models · 1 reports · 4 recalls
- SPII Model Lubinus174 models · 6 reports · 3 recalls
- Endo-Model Knee System - Instruments5 models · 6 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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