SPII Model Lubinus 127-767/26Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Hip Prosthesis Stem - XL long neck,Taper 12/14 · Class 2 · Implant
All models of SPII Model Lubinus (174)
Data updated Oct 18, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575241484), received between Feb 10, 2026 and Feb 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
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 18, 2026.
Reports received per month
Recalls naming this device
- Feb 6, 2024Class IIOpen, Classified
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Z-1297-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Inaccurate Information
INCORRECT DEVICE LASER MARKINGS OF A SPII MODEL LUBINUS HIP STEMS WITH THE ARTICLE REF 127-767/26. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301933 ↗
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-2288-2025 · Jul 15, 2025 · Open, ClassifiedProsthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Z-1296-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
- Z-1299-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Z-1298-2024 · Feb 6, 2024 · Open, ClassifiedSPII Model Lubinus, Long Stem Prosthesis 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page