High RiskFDAfda-Z-1926-2013FALL HAZARD

Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre...

Q: What is being recalled?

Spinefrontier, Inc. is the subject of a medical implants safety report: Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre.... The notice was published on March 14, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 8 units are potentially affected.

Q: Why was this product recalled?

This recall was issued in connection with a fall hazard concern. The full description above contains the FDA's official wording about the defect, affected lots, and impacted distribution — read it carefully.

Q: What should I do if I have this product?

Stop using the product. Check the lot number, model number, or sell-by date against the recall notice above. Then contact Spinefrontier, Inc. or the retailer where you purchased it to request a refund, replacement, or repair. The official FDA page has the most current instructions: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

Q: Is a refund or replacement free?

Yes. Under federal recall procedures, consumers are entitled to a remedy at no cost — typically a full refund, free replacement, or free repair. There is generally no expiration on safety recalls. Keep your receipt if possible, but most agencies require remedies even without proof of purchase.

Q: Has anyone been hurt by this product?

Injury and incident reports are part of the official recall announcement above. If you or a member of your household has been harmed by this product, report the incident to FDA at https://www.fda.gov/safety/report-problem-fda. Reports help the agency identify ongoing risks and pursue follow-up enforcement.

Q: Where can I get more information?

The U.S. Food and Drug Administration (FDA) is the authoritative source for this recall. Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the complete recall notice, lot codes, and the manufacturer's contact information.

Q: Is this an FDA food or cosmetic recall?

This recall is in the FDA's jurisdiction and may cover food, dietary supplements, cosmetics, or related products. Follow the FDA's official guidance in the notice above. If you have consumed the product and are concerned about your health, contact a healthcare provider.

Brand

Spinefrontier, Inc.

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1926-2013.

Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1926-2013.

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-1926-2013.

SpineFrontier, Inc.

Official Source

FDA Recalls

U.S. Food and Drug Administration

Report an Incident

File a Complaint

Reports inform future enforcement

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.

How to report to FDA →File a report at FDA →

Spinefrontier, Inc. Recall FAQ

What is being recalled?

Spinefrontier, Inc. is the subject of a medical implants safety report: Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre.... The notice was published on March 14, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 8 units are potentially affected.

Why was this product recalled?

What should I do if I have this product?

Is a refund or replacement free?

Has anyone been hurt by this product?

Where can I get more information?

Is this an FDA food or cosmetic recall?

Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre...

FDA Recall Notice

Corrective Action (per FDA)

✅ What you should do

Consumer Contact (per FDA)

About the U.S. Food and Drug Administration

📣 Report a food, supplement, or cosmetic problem to the FDA

Spinefrontier, Inc. Recall FAQ

Other recalls from Spinefrontier, Inc.

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