Reported Mar 6, 2019 · Terminated
Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is…
Zimmer Biomet Spine Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet Spine Inc. · 10225 Westmoor Dr · Westminster, CO · 80021-2702
Is this the product you have?
- 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 UsageThe 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
- Lot codes and dates
89 of 89 products
Products covered by this recall # Barcodes Product as published 1 Item Number 2 Lot Number 3 Item Description 4 UDI # 5 Manufacturing Quantity 07.02011.001 6 P141352 (Z00176603) 7 Vitality Shear-off Set Screw 8 00889024003187(01)00889024003187 (10)P141352 9 2,192 devices 07.02011.001 10 P141353 11 Vitality Shear-off Set Screw 12 00889024003187(01)00889024003187 (10)P141353 13 879 devices 07.02011.001 14 P141354 (Z00468651) 15 Vitality Shear-off Set Screw 16 00889024003187(01) 00889024003187 (10)P141354 17 924 devices 07.02011.001 18 P141358 (Z00420148) 19 Vitality Shear-off Set Screw 20 00889024003187(01)00889024003187 (10)P141358 - Amount recalled
- 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Zimmer Biomet Spine Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.