Orthofix recalls specific sizes of TL-HEX TruLok Hexapod System footplates due to incompatibility with newer struts, potentially causing improper bone alignment during healing.
The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.
Orthofix is recalling certain sizes of TL-HEX TruLok Hexapod System footplates made in 2014 that may not fit with struts produced after September 2016. This incompatibility could lead to improper bone alignment during healing, which might require additional surgery.
The footplates from a limited 2014 production period may not fit correctly with struts made after September 2016. This incompatibility could cause improper bone alignment during healing, potentially requiring additional surgery to correct.
Patients using the TL-HEX system for bone healing, particularly those with specific footplate sizes (120mm to 220mm) manufactured in 2014. Patients who have recently had surgery with these footplates are most at risk.
Check for the product name 'TL-HEX TruLok Hexapod System, Double Row Footplates' with sizes 120mm, 140mm, 160mm, 180mm, or 200mm. Look for lot numbers starting with 'V137' or 'R1065030' on the device.
Review the product's lot number and expiration date to confirm if it falls within the recalled batches.
Orthofix received complaints that certain 2014 footplates are incompatible with struts made after September 2016, which could cause improper bone alignment during healing.
No, the recall does not require immediate discontinuation. Patients should check if their footplates are in the recalled batches and contact Orthofix if they have concerns.
Look for lot numbers starting with 'V137' or 'R1065030' on the device, and check the expiration date. The product sizes are 120mm to 200mm.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2063-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2063-2018 from Orthofix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
