LINK Instruments - Trial implants and size gaugesRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one LINK Instruments - Trial implants and size gauges model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of LINK Instruments - Trial implants and size gauges by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Feb 13, 2026 and Feb 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inaccurate Information” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
LINK Instruments - Trial implants and size gauges 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.
- Jul 15, 2025Open, Classified
Inconsistent size terminology and color coding used on labeling
Z-2289-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported LINK Instruments - Trial implants and size gauges problems
Device problems
- Inaccurate Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
LINK Instruments - Trial implants and size gauges models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall0 reports
- 2 reports
Recent LINK Instruments - Trial implants and size gauges adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Inaccurate Information
SMALL RIGHT FEMORAL TRIALS IN STOCK WERE FOUND TO HAVE THE INCORRECT MARK FOR THE SIZE FEATURE; THE PARTS ARE MARKED WITH AN L DESIGNATING LEFT. ALL THE OTHER LASER MARKING ON THE TRIALS IS CORRECT, THE PARTS ARE SMALL RIGHTS, AND THE LABELING REFLECTS SMALL RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330066 ↗MalfunctionFeb 13, 2026Inaccurate Information
SMALL RIGHT FEMORAL TRIALS IN STOCK WERE FOUND TO HAVE THE INCORRECT MARK FOR THE SIZE FEATURE; THE PARTS ARE MARKED WITH AN L DESIGNATING LEFT. ALL THE OTHER LASER MARKING ON THE TRIALS IS CORRECT, THE PARTS ARE SMALL RIGHTS, AND THE LABELING REFLECTS SMALL RIGHT. [CUSTOMER]
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330065 ↗
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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