Endo-Model Knee System - InstrumentsRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Endo-Model Knee System - Instruments model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 5 models of Endo-Model Knee System - Instruments by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2023 and Apr 15, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 Knee System - Instruments 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.
- Nov 30, 2023Open, Classified
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 extended surgery time
Z-0749-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 26, 2023Open, Classified
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 prolongation of surgery or modified surgery
Z-2481-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Endo-Model Knee System - Instruments problems
Device problems
- Fracture4
- Off-Label Use3
- Detachment of Device or Device Component1
- Residue After Decontamination1
- Solder Joint Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient1
- Insufficient Information1
Endo-Model Knee System - Instruments models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Endo-Model Knee System - Instruments 17-5220/01Orthopedic manual surgical instrument1 recall1 report
- Endo-Model Knee System - Instruments 15-2530/05Guide, surgical, instrument1 recall0 reports
- 3 reports
- 1 report
- 1 report
Recent Endo-Model Knee System - Instruments adverse event reports
The 6 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 15, 2026Residue After Decontamination
NOTIFIED LATE ON (B)(6) 2026, THAT A SURGERY WAS GOING TO BE PERFORMED BUT AN INSTRUMENT IN THE CCK TRAY HAD DISCOLORATION ON IT THAT LOOKED LIKE BLOOD OR RUST. THE SURGERY WAS CANCELLED AND PERFORMED ON (B)(6) 2026 INSTEAD, WITH THE INSTRUMENT REMOVED OUT OF THE TRAY. THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE INSTRUMENT WAS NOTICED SO THE SURGERY WAS CANCELLED AND RESCHEDULED FOR THE NEXT DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886721 ↗MalfunctionSep 11, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATELLA CLAMP ARM BROKE AND CAME APART DURING A PROCEDURE AND THE CLIP THAT HOLDS THE ROUND PLASTIC SECTION ON THE ARM WAS LEFT IN THE WOUND. [CUSTOMER]
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23024855 ↗MalfunctionMar 25, 2024Fracture; Off-Label Use; Fracture; Off-Label Use
IT WAS NOTICED DURING A SURGERY THAT THE TIP OF THE 2.0MM HEX SCREWDRIVER WAS BROKEN OFF PRIOR TO USE. [CUSTOMER]
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18966861 ↗MalfunctionJan 19, 2024Fracture; Off-Label Use; Fracture; Off-Label Use
THE TIP OF THE 2.0 MM HEX SCREWDRIVER BROKE OFF WHEN SCREWING IN THE CONNECTING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542258 ↗MalfunctionJan 19, 2024Fracture; Off-Label Use; Fracture; Off-Label Use
THE TIP OF THE 2.0 MM HEX SCREWDRIVER BROKE OFF WHEN SCREWING IN THE CONNECTING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542256 ↗MalfunctionJul 27, 2023Solder Joint Fracture; Solder Joint Fracture
THE RASPHANDLE BROKE WHEN IT WAS BEING HAMMERED IN.[CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17403278 ↗
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 SL Knee Prosthesis System25 models · 52 reports · 6 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
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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