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Recall Observatory FDA recall evidence

Device product

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - 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.

Z-2220-2020

May 05, 2020

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 85613
Status
Terminated
Classification
Class II
Quantity
3235 total
Official record key
device-enforcement:Z-2220-2020

Official wording

Reason: 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.

Code information: UDI: (01)00887868324864; Lot Numbers: C19G0005 C19H0015 C19I0014 C19J0014 C19K0012 C19L0006 C20A0007 C20A0014 C20A0015 C20B0007 C20B0008 C20B0009 SBM108410 SBM109981 SBM109982 SBM109983 SBM118992

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.