Reported Dec 26, 2012 · Terminated
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard…
Titan Spine, LLC
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: TITAN SPINE, LLC · 6140 W Executive Dr · Mequon, WI · 53092-4499
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
18mm | Titan Spine Endoskeleton TA Implant products. 2107-0118 |
20mm | Standard Endoskeleton Implant VBR 2107-0120 |
18mm | Standard Endoskeleton Implant VBR 2107-0218 |
20mm | Large Endoskeleton Implant VBR 2107-0220 |
- Lot codes and dates
- Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.
- Amount recalled
- 92 pcs.
Where it was sold
- Nationwide
- NV
Why it was recalled
Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
This product could cause temporary or reversible health problems — stop using it.
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