The Tether™ 211H6040Recalls & reported problems
Zimmer Biomet Inc · 6.0MM DIA X 40MM VBT ASSY · Class N
All models of The Tether (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304864979), received between Mar 29, 2024 and Mar 29, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Unintended Movement” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement2
Patient problems
- Spinal Column Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS CURVE PROGRESSION AND SUSPECTED TETHER CORD BREAKAGE. A POSTERIOR SCREW CONSTRUCT WAS ADDED DURING THE REVISION WITHOUT REMOVING THE TETHER CONSTRUCT. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.
Patient problems: Spinal Column Injury
MAUDE report 19003642 ↗InjuryMar 29, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS CURVE PROGRESSION AND SUSPECTED TETHER CORD BREAKAGE. A POSTERIOR SCREW CONSTRUCT WAS ADDED DURING THE REVISION WITHOUT REMOVING THE TETHER CONSTRUCT. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.
Patient problems: Spinal Column Injury
MAUDE report 19003619 ↗
Other Vertebral Body Tethering System devices
- The Tether™ 204H0300Zimmer Biomet Inc · Vertebral Body Tethering System29 reports
- The Tether™ 203H0012Zimmer Biomet Inc · Vertebral Body Tethering System6 reports
- The Tether™ 211H6032Zimmer Biomet Inc · Vertebral Body Tethering System6 reports
- The Tether™ 211H6030Zimmer Biomet Inc · Vertebral Body Tethering System4 reports
- The Tether™ 211H6035Zimmer Biomet Inc · Vertebral Body Tethering System3 reports
- The Tether™ 211H7040Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H7037Zimmer Biomet Inc · Vertebral Body Tethering System2 reports
- The Tether™ 211H7035Zimmer Biomet Inc · Vertebral Body Tethering System2 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
- 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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