Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indi

FDA device recall Z-0867-2019 · posted 2019-02-22 · Terminated

Recall details

Recalling firm

Zimmer Biomet Spine Inc.

Reason for recall

The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

Action taken

On August 30, 2018 a Urgent Medical Recall notification letter was sent to Distributors and Hospital Risk Managers notifying them of the Zimmer Biomet Vitality Shear-off Set Screw recall. The notification letter described the potential risks associated to the recall and steps they needed to follow to mitigate those potential risk. The responisbilities as described by Zimmer Biomet to the customers is as follows: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. b. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-447-3625 between 8:00 am and 5:00pm MST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an o

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KWP

Quantity affected

16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation)

Distribution

Distributed Nationwide: AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA and WI.**** International distribution: Australia and EMEA.

Date initiated

2018-07-30

Date posted

2019-02-22

Date terminated

2021-04-28

Location

Westminster, CO

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