HIGH V+ SPINAL CEMENT SYSTEM T040321KRecalls & reported problems
Teknimed · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Dec 15, 2022Open, Classified
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Z-1099-2023 · Root cause: Employee error · FDA record ↗
Other Cement, Bone, Vertebroplasty devices
- CONFIDENCE SPINAL CEMENT SYSTEM 283910000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY5 deaths163 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283913000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY8 deaths146 reports
- KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01BMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY3 deaths67 reports
- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705310000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.