LINK Embrace Shoulder System Line Extension 645-081/62Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Surgical drill guide, reusable - LINK Embrace Shoulder System · Class 1
All models of LINK Embrace Shoulder System Line Extension (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name 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
- 3
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575534715), 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).
3 FDA recall records name this device's 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, 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 11, 2026Class IIOpen, 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, 2026Class IIOpen, 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, 2024Class IIOpen, 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 problems
Device problems
- Inadequate Instructions for Healthcare Professional1
- Unclear 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 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 Bit, Drill devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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.
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