Z-2233-2020Class II

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

Name: Z-2233-2020 Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 -
Creator: Zimmer Biomet, Inc.
Published: 2020-05-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-05-05 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for... on 2020-05-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2233-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-05
Posted: 2020-06-02
Terminated: 2022-07-15
Recalling firm: Zimmer GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA 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 [email protected]. 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 [email protected]. 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 in commerce: 3235 total
Distribution: US nationwide distribution.
Product codes and lots: UDI: (01)00887868310140; Lot Numbers: 136158 136158 143757 311626

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2233-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2210-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2211-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2212-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2213-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2214-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2215-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2216-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2217-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2218-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2219-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2220-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2221-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2222-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2223-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2224-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2225-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2226-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2227-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2228-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2229-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2230-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2231-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2232-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2233-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2234-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code LXH

K183550Class IIVitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. / cleared 2019-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)