FDA Medical Device Recalls (openFDA)
Orthofix U.S. LLC: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
- Recall number
- Z-2732-2026
- Recalling firm
- Orthofix U.S. LLC
- Product
- Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
- Status
- Open, Classified
- Initiated
- 2026-06-10
- Posted
- 2026-07-14
- Terminated
- not on file
- Reason
- 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
- Root cause
- Process change control
- Action
- On June 8, 2026, Orthofix issued a Urgent Medical Device Recall Notification, via E.Mail. Orthofix asked consignees to take the following actions: 1.Discontinue use of the affected product lots immediately. 2.Immediately examine your inventory and quarantine any affected product and return them to Orthofix. 3. Complete the attached response form and return it to Orthofix. 4. This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred.
- Quantity
- 62 units
- Distribution
- US: 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 OUS: None
- Lot, serial or model codes
- All Lots; GTIN# 18032568866711
- 510(k) numbers
- ["K113770"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28