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Vital recallZ-2216-2020 · Zimmer Biomet, Inc. · initiated May 5, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2216-2020
Status
Terminated
Initiated by the company
May 5, 2020
Recalling firm
Zimmer Biomet, Inc.
Quantity
3235 total
Product code
NKB
FDA submissions
K183550
Distribution
US nationwide distribution.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 85613).

Sources and updates

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