InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1666-2013.
Potential for set screw to be come deformed.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1666-2013.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Spinefrontier, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1666-2013.
SpineFrontier, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Spinefrontier, Inc. Recall FAQ
Spinefrontier, Inc. is the subject of a medical implants safety report: InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an.... The notice was published on May 7, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 61 units are potentially affected.