The Recall Desk
HighFDA (Devices)·Z-0866-2019·Announced 2019-03-06

Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

Zimmer Biomet is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

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 structural failure in a spinal implant where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer Biomet Spine Inc. is recalling the Vitality Shear-off Set Screws, which are part of the Vitality Spinal Fixation System. The recall involves 16,429 devices distributed nationwide across 27 U.S. states, as well as internationally in Australia and the EMEA region.

The recall was initiated because the set screws are not threading properly with the mating tulip head of the Vitality screws, hooks, and connectors. This defect is attributed to a manufacturing issue. These devices are indicated as an adjunct to fusion for various orthopedic indications in skeletally mature and adolescent patients.

Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet Spine Inc. for further instructions on the recall process.

The recalled product

Product
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 i
Manufacturer
Zimmer Biomet Spine Inc.
Category
Medical Device — Orthopedic Implant
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 →

Related recalls

Same manufacturer · Zimmer Biomet Spine Inc.

See all →

Same hazard · manufacturing defect

See all →