LINK Embrace Shoulder System Line ExtensionRecalls & 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
4 open recalls name at least one LINK Embrace Shoulder System Line Extension model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 2 models of LINK Embrace Shoulder System Line Extension by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (1 report).
4 FDA recall records name at least one of these models by its device identifier, 4 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 Embrace Shoulder System Line Extension 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 11, 2026Open, Classified
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Z-1652-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 11, 2026Open, Classified
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Z-1651-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 29, 2024Open, Classified
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
Z-1258-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 29, 2024Open, Classified
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
Z-1257-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported LINK Embrace Shoulder System Line Extension problems
Device problems
- Inadequate Instructions for Healthcare Professional1
- Unclear Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
LINK Embrace Shoulder System Line Extension models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3 recalls1 report
- 1 recall0 reports
Recent LINK Embrace Shoulder System Line Extension adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Inadequate Instructions for Healthcare Professional; Unclear Information
IT WAS NOTICED THAT THE SURGICAL TECHNIQUE FOR THE EMBRACE SHOULDER INSTRUMENTS - DRILL TOWER (ARTICLE REF 645-081/62 &/63) HAVE MIXED-UP ARTICLE NUMBERS IN THE OVERVIEW OF THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233045 ↗
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
- SPII Model Lubinus174 models · 6 reports · 3 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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