SPII Model LubinusRecalls & reported problems across all models
WALDEMAR LINK GmbH & Co. KG · 174 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one SPII Model Lubinus 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
- 4
- Recalls
- 3
We found 174 models of SPII Model Lubinus 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 Jan 26, 2023 and Feb 10, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
SPII Model Lubinus 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.
- Feb 6, 2024Open, 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-1298-2024 · Root cause: Under Investigation by firm · names 48 of these models · Recall details · FDA record ↗
- Feb 6, 2024Open, 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 · names 27 of these models · Recall details · FDA record ↗
- Feb 6, 2024Open, 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-1296-2024 · Root cause: Under Investigation by firm · names 99 of these models · Recall details · FDA record ↗
Most reported SPII Model Lubinus problems
Device problems
- Fracture4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Inaccurate Information1
- Off-Label Use1
- Unclear Information1
Patient problems
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
- Periprosthetic fracture1
- Unspecified Infection1
SPII Model Lubinus models
174 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- SPII Model Lubinus 127-720/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall2 reports
- SPII Model Lubinus 127-728/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-922/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-721/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-767/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall1 report
- SPII Model Lubinus 127-712/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-712/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-713/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-713/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-714/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-714/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-715/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-715/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-716/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-716/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-717/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-717/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-718/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-718/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-719/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-719/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-722/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-722/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-723/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-723/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-724/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-724/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-725/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-725/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-726/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-726/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-727/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-727/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-728/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-729/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-729/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-730/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-730/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-731/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-731/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-732/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-732/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-733/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-733/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-910/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-910/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-911/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-911/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-912/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-912/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-913/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-913/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-914/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-914/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-915/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-915/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-916/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-916/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-917/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-917/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-918/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-918/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-919/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-919/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-920/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-920/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-921/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-921/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-922/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-923/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-923/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-924/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-924/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-925/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-925/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-926/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-926/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-927/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-927/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-928/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-928/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-929/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-929/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-930/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-930/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-931/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-931/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-932/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-932/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-933/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-933/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-736/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-736/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-720/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-738/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-738/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-737/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-737/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-739/26Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
- SPII Model Lubinus 127-739/35Prosthesis, Hip, Femoral Component, Cemented, Metal1 recall0 reports
Recent SPII Model Lubinus adverse event reports
The 6 most recent reports across all models, 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 ↗InjuryJun 6, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
FRACTURE OF THE PROSTHESIS STEM [CUSTOMER].
Patient problems: Bone Fracture(s); Failure of Implant; Periprosthetic fracture
MAUDE report 19475314 ↗MalfunctionFeb 5, 2024Unclear Information; Unclear Information
"CUSTOMER PERFORMED SURGERY ACCORDING TO SURGICAL TECHNIQUE. TRIAL REDUCTION WAS DONE WITH 126 XL NECK SEGMENT, WHICH WAS THEN SELECTED FOR DEFINITIVE IMPLANT (R4 W/ XL NECK). WHEN CIRCULATING NURSE SHOWED THE IMPLANT LABEL TO SURGEON BEFORE OPENING THE PACKAGE, THE SIZE MARKING ON THE LABEL ("X-LARGE R4") WAS MISINTERPRETED AS "XL-NECK R4". STEM WAS THEN IMPLANTED AND IT WAS NOTICED ONLY AFTER THE CEMENT WAS CURED THAT IT HAD STANDARD NECK BUT NOT XL." [CUSTOMER]
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18639792 ↗InjuryAug 9, 2023Fracture; Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 22, 2023Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJan 26, 2023Fracture; Fracture
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
- Endo-Model Knee System - Instruments5 models · 6 reports · 2 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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