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

Class I - Dangerous

🏥 Medical Devices Recalled: July 30, 2018 Zimmer Biomet Spine Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141353; 879 devices 07.02011.001; P141354 (Z00468651); Vitality Shear-off Set Screw; (01) 00889024003187 (10)P141354; 924 devices 07.02011.001; P141358 (Z00420148); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141358; 2,193 devices 07.02011.001; P141359 (Z00274115); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141359; 868 devices 07.02011.001; P141360; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141360; 872 devices 07.02011.001; P142510; Vitality Shear-off Set Screw; (01)00889024003187 (10)P142510; 3,045 devices 07.02011.001; W505611; Vitality Shear-off Set Screw; (01)00889024003187 (10)W505611; 1,545 devices 07.02011.001; W508041; Vitality Shear-off Set Screw; (01)00889024003187 (10)W508041; 1,497 devices 07.02011.001; W509651; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509651; 3,396 devices 07.02011.001; W509661; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509661; 3,382 devices 07.02011.001; W5096619; Vitality Shear-off Set Screw; (01)00889024003187 (10)W5096619; 61 devices 07.02011.001; W526991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W526991; 799 devices 07.02011.001; W529371; Vitality Shear-off Set Screw; (01)00889024003187 (10)W529371; 823 devices 07.02011.001; W530301; Vitality Shear-off Set Screw; (01)00889024003187 (10)W530301; 1,342 devices 07.02011.001; W546001; Vitality Shear-off Set Screw; (01)00889024003187 (10)W546001; 634 devices 07.02011.001; W554821; Vitality Shear-off Set Screw; (01)00889024003187 (10)W554821; 2,110 devices 07.02011.001; W559871; Vitality Shear-off Set Screw; (01)00889024003187 (10)W559871; 1,461 devices 07.02011.001; W573501; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573501; 2,713 devices 07.02011.001; W573511; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573511; 2,698 devices 07.02011.001; W577991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W577991; 2,026 devices
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: 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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141353; 879 devices 07.02011.001; P141354 (Z00468651); Vitality Shear-off Set Screw; (01) 00889024003187 (10)P141354; 924 devices 07.02011.001; P141358 (Z00420148); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141358; 2,193 devices 07.02011.001; P141359 (Z00274115); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141359; 868 devices 07.02011.001; P141360; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141360; 872 devices 07.02011.001; P142510; Vitality Shear-off Set Screw; (01)00889024003187 (10)P142510; 3,045 devices 07.02011.001; W505611; Vitality Shear-off Set Screw; (01)00889024003187 (10)W505611; 1,545 devices 07.02011.001; W508041; Vitality Shear-off Set Screw; (01)00889024003187 (10)W508041; 1,497 devices 07.02011.001; W509651; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509651; 3,396 devices 07.02011.001; W509661; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509661; 3,382 devices 07.02011.001; W5096619; Vitality Shear-off Set Screw; (01)00889024003187 (10)W5096619; 61 devices 07.02011.001; W526991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W526991; 799 devices 07.02011.001; W529371; Vitality Shear-off Set Screw; (01)00889024003187 (10)W529371; 823 devices 07.02011.001; W530301; Vitality Shear-off Set Screw; (01)00889024003187 (10)W530301; 1,342 devices 07.02011.001; W546001; Vitality Shear-off Set Screw; (01)00889024003187 (10)W546001; 634 devices 07.02011.001; W554821; Vitality Shear-off Set Screw; (01)00889024003187 (10)W554821; 2,110 devices 07.02011.001; W559871; Vitality Shear-off Set Screw; (01)00889024003187 (10)W559871; 1,461 devices 07.02011.001; W573501; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573501; 2,713 devices 07.02011.001; W573511; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573511; 2,698 devices 07.02011.001; W577991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W577991; 2,026 devices

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0866-2019

Related Recalls

Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

Zimmer Biomet Spine

Class I - Dangerous

Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.

Oct 16, 2023 Other Medical Devices Nationwide View Details →

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 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

Zimmer Biomet Spine

Class I - Dangerous

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

Jul 30, 2018 Other Medical Devices Nationwide View Details →

Vitality¿ Spinal Fixation System. Spinal Interlaminal, 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 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.

Zimmer Biomet Spine

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