Prosthesis Head BRecalls & 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 Prosthesis Head B model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of Prosthesis Head B by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2026 and May 7, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
Prosthesis Head B 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-2288-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Prosthesis Head B problems
Device problems
- Unsealed Device Packaging2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Prosthesis Head B models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prosthesis Head B 198-828/04Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- Prosthesis Head B 128-832/01Prosthesis, Hip, Femoral Component, Cemented, Metal3 reports
Recent Prosthesis Head B adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Unintended Movement
THE ENTIRE SCREW, INCLUDING THE HEAD, SLIPPED THROUGH THE HOLE IN THE CUP. [CUSTOMER]
Patient problems: Pain
MAUDE report 25108420 ↗MalfunctionApr 30, 2026Unsealed Device Packaging
DEFECT IN SEALED SEAM OF THE OUTER STERILE POUCH [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25041903 ↗MalfunctionMar 4, 2026Unsealed Device Packaging
DEFECT IN SEALED EDGE IN OUTER PLASTIC PACKAGE (CUSTOMER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510962 ↗
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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