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 prop
Check against the official notice below — it lists the full affected range.
Zimmer Biomet Spine Inc. is recalling approximately 16,429 Vitality Shear-off Set Screws used in spinal fixation systems due to a manufacturing defect. The set screws are not threading properly with the mating tulip head components of Vitality screws, hooks, and connectors. These devices are used as an adjunct to spinal fusion surgery for skeletally mature patients and adolescents. The affected products were distributed nationwide across 27 U.S. states and internationally to Australia and countries in the EMEA region.
The recall involves multiple lot numbers of the Vitality Shear-off Set Screw component, with specific lot codes ranging from P141352 through W529371. The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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. Quantity: 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation) Lot/code info: 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 07.02
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.