Zimmer Biomet, Inc.: 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

Is my product affected?

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 m

• UPC 00887868324864

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. is recalling 3,235 units of the Vital MIS Spinal Fixation system extended tab screws (Item Number 810M6545) distributed nationwide in the United States. These are non-cervical spinal fixation devices intended for posterior pedicle use. The recall was initiated due to reports of inadequate locking of the extended tab screws, with complaints indicating that the closure top backed out of the screw after surgery.

The affected implants are identified by UDI (01)00887868324864 and the following lot numbers: C19G0005, C19H0015, C19I0014, C19J0014, C19K0012, C19L0006, C20A0007, C20A0014, C20A0015, C20B0007, C20B0008, C20B0009, SBM108410, SBM109981, SBM109982, SBM109983, and SBM118992. The source document does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: US nationwide distribution. Quantity: 3235 total Lot/code info: UDI: (01)00887868324864; Lot Numbers: C19G0005 C19H0015 C19I0014 C19J0014 C19K0012 C19L0006 C20A0007 C20A0014 C20A0015 C20B0007 C20B0008 C20B0009 SBM108410 SBM109981 SBM109982 SBM109983 SBM118992

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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