Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ORTHOFIX Catalogue Number: ref 1-1355001 Recalled by Orthofix Srl Due to As a result of complaint investigations it was...

Date: September 27, 2018
Company: Orthofix Srl
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix Srl directly.

Affected Products

ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918

Quantity: N/A

Why Was This Recalled?

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Where Was This Sold?

This product was distributed to 28 states: AZ, CA, FL, GA, HI, IL, IN, IA, KY, LA, MD, MI, MS, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI

Affected (28 states)Not affected

About Orthofix Srl

Orthofix Srl has 34 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report