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Use caution Medical device recall · FDA · Published May 5, 2020

Zimmer Biomet Spinal Fixation Implants Recall: Inadequate Screw Locking Risk

Zimmer Biomet recalls certain spinal fixation implants due to reports of screws backing out post-surgery. Affected items have specific model numbers and lot codes. Consumers should contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2214-2020Medical deviceZimmer Biomet ›
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Contact the company

Recalling firmZimmer Biomet, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling specific spinal fixation implants that may back out after surgery. This could lead to complications if the implant loosens during healing. Read more at govinfonow.com/recall/65221-zimmer-biomet-spinal-fixation-implants-recall-inadequate-screw-locking-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65221-zimmer-biomet-spinal-fixation-implants-recall-inadequate-screw-locking-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2214-2020

Cite this page

“Zimmer Biomet Spinal Fixation Implants Recall: Inadequate Screw Locking Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65221-zimmer-biomet-spinal-fixation-implants-recall-inadequate-screw-locking-risk. Based on FDA recall #Z-2214-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2214-2020%22&limit=1).

The FDA announced on May 5, 2020, that Zimmer Biomet, Inc. is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws. The agency issued recall number Z-2214-2020 for the Class II device distributed nationwide.

How to tell if you have it

  • Brand: Zimmer Biomet
  • Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM
  • Item Number: 810M5535
  • UPC: 00887868324420
  • Lot Numbers: C19H0007, C19J0004, C19K0001, C19K0003, C20A0002, SBM108403, SBM118985, SBM122395
  • Units affected: 3235

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.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Other recent recalls include a Nov. 20, 2020 spinal rod cutter recall for fracture risk and a Sept. 24, 2020 hip cup recall involving sterilant risks. Similar product recalls include a May 20, 2026 Zimmer Off-Axis Shoulder System recall for plastic guide breakage and a May 11, 2026 Zimmer Persona Revision Femoral Distal Augment recall.

How to tell if you have this one

Check the item number 810M5535 on the implant packaging. The affected lot numbers include C19H0007, C19J0004, C19K0001, C19K0003, C20A0002, SBM108403, and SBM118985.

  • Brand
    Zimmer Biomet
  • Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535
  • Category
    Medical device
FDA recall event · 25 products

All 25 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US nationwide distribution.
Recall numberProduct, codes & lots
Z-2210-2020Vital 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
Z-2211-2020Vital 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
Z-2212-2020Vital 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
Z-2213-2020Vital 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
Z-2214-2020Vital 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
Z-2215-2020Vital 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
Z-2216-2020Vital 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
Z-2217-2020Vital 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
Z-2218-2020Vital 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
Z-2219-2020Vital 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
Z-2220-2020Vital 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
Z-2221-2020Vital 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
Z-2222-2020Vital 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
Z-2223-2020Vital 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
Z-2224-2020Vital 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
Z-2225-2020Vital 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
Z-2226-2020Vital 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
Z-2227-2020Vital 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
Z-2228-2020Vital 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
Z-2229-2020Vital 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
Z-2230-2020Vital 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
Z-2231-2020Vital 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
Z-2232-2020Vital 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
Z-2233-2020Vital 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
Z-2234-2020Vital 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
Based on the official FDA remedy

What to do — step by step

  1. Contact Zimmer Biomet

    Reach out to Zimmer Biomet directly for specific instructions on how to handle the recalled implants.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: May 5, 202012. FDA classified it Class II: Jun 2, 202023. Published in FDA’s Enforcement Report: Jun 10, 202034. FDA terminated the recall: Jul 15, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2214-2020 (May 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2214-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA