Zimmer Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2214-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 5, 2020

Date Posted: June 10, 2020

Recall Number: Z-2214-2020

Event ID: 85613

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.

Status: Terminated

Product Quantity: 3235 total

Code Information:

UDI: (01)00887868324420; Lot Numbers: C19H0007 C19J0004 C19K0001 C19K0003 C20A0002 SBM108403 SBM118985 SBM122395

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated