Zimmer Biomet, Inc.: 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.

Recall number

Z-2211-2020

Recalling firm

Zimmer Biomet, Inc.

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.

Status

Terminated

Initiated

2020-05-05

Posted

not on file

Terminated

2022-07-15

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.

Root cause

Under Investigation by firm

Action

URGENT MEDICAL DEVICE RECALL notification letters dated 5/5/20 were sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-447-3625 between 8:00 am and 6:00pm MST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. Patients should continue with the post-operative care as scheduled by their surgeon who typically assess the construct as part of their evaluation(s). During these visits, surgeons should compare follow up radiographs to the immediate post-op radiographs to determine if the Closure Tops have loosened. Additionally, consider doing dynamic imaging such as flexion/extension to detect implant movement when appropriate. If Closure Top loosening and/or migration is noted, surgeon may consider surgical intervention. During this surgical intervention, consideration should be made regarding replacement of the closure tops as well as the screws. 3. Complete Attachment 1 Certificate of Ackn

Quantity

3235 total

Distribution

US nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

["K183550"]

PMA numbers

not on file

Product code

NKB

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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