The Recall Desk
HighFDA (Devices)·Z-0868-2019·Announced 2019-03-06

Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because a manufacturing issue prevents them from threading properly with mating components.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a mechanical failure in a spinal fixation device. While no injuries are reported, the potential for harm from a non-threading spinal implant component places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Biomet Spine Inc. is recalling the Vitality Shear-off Set Screw, a component of the Vitality Spinal Fixation System. The recall involves 16,429 devices distributed nationwide across 27 U.S. states as well as internationally to Australia and the EMEA region. These devices are indicated as an adjunct to fusion for various orthopedic indications in skeletally mature and adolescent patients.

The recall was initiated due to a manufacturing issue that causes the Vitality Shear-off Set Screw to not thread properly with the mating tulip head of the Vitality screws, hooks, and connectors. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare providers and patients who have used or may have used these devices should contact Zimmer Biomet Spine Inc. for further instructions. The recall covers specific lot numbers and item numbers detailed in the agency's structured product information.

The recalled product

Product
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (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
Manufacturer
Zimmer Biomet Spine Inc.
Category
Medical Device — Orthopedic / Spinal Fixation
Hazard
Affected units
16,429

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item Number
  • Lot Number
  • Item Description
  • UDI #
  • Manufacturing Quantity 07.02011.001
  • P141352 (Z00176603)
  • Vitality Shear-off Set Screw
  • (01)00889024003187 (10)P141352
  • 2
  • 192 devices 07.02011.001
  • P141353
  • (01)00889024003187 (10)P141353
  • 879 devices 07.02011.001
  • P141354 (Z00468651)
  • (01) 00889024003187 (10)P141354
  • 924 devices 07.02011.001
  • P141358 (Z00420148)
  • (01)00889024003187 (10)P141358
  • 193 devices 07.02011.001
  • P141359 (Z00274115)

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Zimmer Biomet Spine Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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Same manufacturer · Zimmer Biomet Spine Inc.

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