FDAFDA · Food and drugs·Recall number Z-2214-2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.
Published June 10, 2020 · Recall initiated: May 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US nationwide distribution.
- Lot
- UDI: (01)00887868324420; Lot Numbers: C19H0007 C19J0004 C19K0001 C19K0003 C20A0002 SBM108403 SBM118985 SBM122395
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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