Vitality recallZ-0866-2019 · Zimmer Biomet Spine Inc. · initiated Jul 30, 2018

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. 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 [email protected]. 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

Recall details

Recall number

Z-0866-2019

Status

Terminated

Initiated by the company

Jul 30, 2018

Posted by the FDA

Feb 22, 2019

Recalling firm

Zimmer Biomet Spine Inc.

Quantity

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

Product code

NKB

FDA submissions

K150896, K171907

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.

Product description

Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: 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

Devices named in this recall

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

• Vitality® 07.02011.001

  Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 recalls0 reports

Product lines

• VitalityBiomet Spine LLC · 38 models · 157 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 82076).

• Z-0867-2019 · Terminated
  Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent pati…
• Z-0868-2019 · Terminated
  Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescen…