Zimmer Biomet, Inc.: 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.

Agency Publication Date: June 2, 2020

Affected Products

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - 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.

UDI: (01)00887868324185; Lot Numbers: C20B0005 SBM108399 SBM118981 SBM120359

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - 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.

UDI: (01)00887868324192; Lot Numbers: C20B0010 SBM108400 SBM118982 SBM121611

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - 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.

UDI: (01)00887868324208; Lot Numbers: C20B0006 SBM108401 SBM118983 SBM121852 SBM122267

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - 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.

UDI: (01)00887868324215; Lot Numbers: C20B0011 SBM108402 SBM118984

Lot Numbers:

Numbers

Product: 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.

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

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - 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.

UDI: (01)00887868324437; Lot Numbers: C19G0006 C19H0009 C19I0006 C19J0008 C19K0006 C19L0017 SBM108404 SBM118986 SBM121778

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - 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.

UDI: (01)00887868324444; Lot Numbers: C19G0009 C19J0010 C19K0007 C20A0006 SBM108405 SBM118987 SBM121612 SBM122396 SBM122551

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - 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.

UDI: (01)00887868324451; Lot Numbers: C19H0010 C19I0008 C19J0012 C19K0008 C20A0005 SBM108406 SBM118988 SBM122122

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - 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.

UDI: (01)00887868324468; Lot Numbers: C19H0011 C19J0006 C19K0002 C20A0004 SBM108407 SBM118989 SBM121810

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - 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.

UDI: (01)00887868324840; Lot Numbers: C19H0013 C19I0009 C19J0009 C19K0010 C20A0003 SBM108408 SBM118990

Lot Numbers:

Numbers

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.

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

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - 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.

UDI: (01)00887868324871; Lot Numbers: C19H0017 C19I0018 C19J0016 C19L0007 C19L0014 C20A0001 SBM108411 SBM118993 SBM122201 SBM122311

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - 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.

UDI: (01)00887868324888; Lot Numbers: C19I0001 C19I0010 C19J0020 C19L0003 C20A0018 SBM108412 SBM118994

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - 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.

UDI: (01)00887868325267; Lot Numbers: C19I0017 C19J0021 C19L0002 C19L0004 C20A0016 C20A0017 SBM108413 SBM118995 SBM121779

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - 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.

UDI: (01)00887868324857; Lot Numbers: C19H0014 C19I0015 C19J0013 C19K0011 C19L0012 C19L0015 C19L0016 SBM108409 SBM118991 SBM122159

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - 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.

UDI: (01)00887868325281; Lot Numbers: C19I0005 C19I0016 C19J0018 C19L0010 C20A0009 C20A0011 C20A0013 SBM108415 SBM118997 SBM120813 SBM122160

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - 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.

UDI: (01)00887868325298; Lot Numbers: C19I0004 C19J0002 C19J0022 C19L0009 C20B0003 SBM108416 SBM118998 SBM122215 SBM123980

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - 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.

UDI: (01)00887868325304; Lot Numbers: C19I0007 C19J0001 C19J0015 C19L0011 C20B0001 C20B0002 SBM108417 SBM118999 SBM121853

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - 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.

UDI: (01)00887868326110; Lot Numbers: SBM109984

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - 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.

UDI: (01)00887868326127; Lot Numbers: SBM108419

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - 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.

UDI: (01)00887868326134; Lot Numbers: SBM108420

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - 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.

UDI: (01)00887868326141; Lot Numbers: SBM109985 SBM109986

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - 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.

UDI: (01)00887868326158; Lot Numbers: SBM111598

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - 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.

UDI: (01)00887868310140; Lot Numbers: 136158 136158 143757 311626

Lot Numbers:

Numbers

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - 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.

UDI: (01)00887868325274; Lot Numbers: C19I0003 C19I0020 C19J0017 C19L0008 C20B0004 SBM108414 SBM118996 SBM120650 SBM122346

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85613

Status: Resolved

Manufacturer: Zimmer Biomet, Inc.

Manufactured In: United States

Units Affected: 25 products (3235 total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

UDI: (01)00887868324185; Lot Numbers: C20B0005 SBM108399 SBM118981 SBM120359

Lot Numbers:

Numbers

UDI: (01)00887868324192; Lot Numbers: C20B0010 SBM108400 SBM118982 SBM121611

Lot Numbers:

Numbers

UDI: (01)00887868324208; Lot Numbers: C20B0006 SBM108401 SBM118983 SBM121852 SBM122267

Lot Numbers:

Numbers

UDI: (01)00887868324215; Lot Numbers: C20B0011 SBM108402 SBM118984

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

UDI: (01)00887868324437; Lot Numbers: C19G0006 C19H0009 C19I0006 C19J0008 C19K0006 C19L0017 SBM108404 SBM118986 SBM121778

Lot Numbers:

Numbers

UDI: (01)00887868324444; Lot Numbers: C19G0009 C19J0010 C19K0007 C20A0006 SBM108405 SBM118987 SBM121612 SBM122396 SBM122551

Lot Numbers:

Numbers

UDI: (01)00887868324451; Lot Numbers: C19H0010 C19I0008 C19J0012 C19K0008 C20A0005 SBM108406 SBM118988 SBM122122

Lot Numbers:

Numbers

UDI: (01)00887868324468; Lot Numbers: C19H0011 C19J0006 C19K0002 C20A0004 SBM108407 SBM118989 SBM121810

Lot Numbers:

Numbers

UDI: (01)00887868324840; Lot Numbers: C19H0013 C19I0009 C19J0009 C19K0010 C20A0003 SBM108408 SBM118990

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

UDI: (01)00887868324871; Lot Numbers: C19H0017 C19I0018 C19J0016 C19L0007 C19L0014 C20A0001 SBM108411 SBM118993 SBM122201 SBM122311

Lot Numbers:

Numbers

UDI: (01)00887868324888; Lot Numbers: C19I0001 C19I0010 C19J0020 C19L0003 C20A0018 SBM108412 SBM118994

Lot Numbers:

Numbers

UDI: (01)00887868325267; Lot Numbers: C19I0017 C19J0021 C19L0002 C19L0004 C20A0016 C20A0017 SBM108413 SBM118995 SBM121779

Lot Numbers:

Numbers

UDI: (01)00887868324857; Lot Numbers: C19H0014 C19I0015 C19J0013 C19K0011 C19L0012 C19L0015 C19L0016 SBM108409 SBM118991 SBM122159

Lot Numbers:

Numbers

UDI: (01)00887868325281; Lot Numbers: C19I0005 C19I0016 C19J0018 C19L0010 C20A0009 C20A0011 C20A0013 SBM108415 SBM118997 SBM120813 SBM122160

Lot Numbers:

Numbers

UDI: (01)00887868325298; Lot Numbers: C19I0004 C19J0002 C19J0022 C19L0009 C20B0003 SBM108416 SBM118998 SBM122215 SBM123980

Lot Numbers:

Numbers

UDI: (01)00887868325304; Lot Numbers: C19I0007 C19J0001 C19J0015 C19L0011 C20B0001 C20B0002 SBM108417 SBM118999 SBM121853

Lot Numbers:

Numbers

UDI: (01)00887868326110; Lot Numbers: SBM109984

Lot Numbers:

Numbers

UDI: (01)00887868326127; Lot Numbers: SBM108419

Lot Numbers:

Numbers

UDI: (01)00887868326134; Lot Numbers: SBM108420

Lot Numbers:

Numbers

UDI: (01)00887868326141; Lot Numbers: SBM109985 SBM109986

Lot Numbers:

Numbers

UDI: (01)00887868326158; Lot Numbers: SBM111598

Lot Numbers:

Numbers

UDI: (01)00887868310140; Lot Numbers: 136158 136158 143757 311626

Lot Numbers:

Numbers

UDI: (01)00887868325274; Lot Numbers: C19I0003 C19I0020 C19J0017 C19L0008 C20B0004 SBM108414 SBM118996 SBM120650 SBM122346

Lot Numbers:

Numbers