Vitality¿ Spinal Fixation System. Thoracolumbosacral recall
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature…
Why was Vitality¿ Spinal Fixation System. Thoracolumbosacral 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature…
- Recalling firm
- Zimmer Biomet Spine Inc.
- Quantity
- 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation)
- 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.
- Recall date
- March 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)