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TRANSLACE™ Spinal Tethering System
MEDTRONIC SOFAMOR DANEK, INC. · Model 8239000 · UDI-DI 00763000675035
OWI
Prescription
1
510(k) clearances
68
Adverse events
2
Recalls
64
Facilities
Description
TENSIONER 8239000 TENSIONER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-08 | Medicrea International | Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-interv |
| 2017-04-24 | OrthoPediatrics Corp | Over-tensioning of the band resulting in damage to the band causing it to rupture |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.