Orthofix U.S. LLC recalls Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF:
See all recalls from Orthofix U.S. LLC →Recalled Product
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Hazard / Issue
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Issued by
FDA
Affected States: AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MD, MI, MO, MS, MT, NC, NY, OH, OR, SC, SD, TX, UT, VA, WA, WI
Lot/Code Info: All Lots; GTIN# 18032568866711
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Orthofix MINIRAIL, ARTICULATED, FIXATOR, →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime