Prosthesis Head B 198-828/04Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Class 2 · Implant
All models of Prosthesis Head B (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K953653); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K953653. One submission often covers many models, so check the product and lot details in each record.
- Z-1298-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
- Z-1297-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
- Z-1299-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Z-1296-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Other Prosthesis, Hip, Femoral Component, Cemented, Metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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