Orthofix recalls sterile TN plates for surgery due to locking screws not engaging plates during procedures. Affected items have specific part numbers and UDI lots. Consumers should contact Orthofix for details.
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Orthofix is recalling sterile TN plates used in surgery because the locking screws may not properly engage with the plates during surgery. This could lead to improper fixation of bones and potential complications for patients.
The locking screws in the recalled plates may not properly engage with the plates during surgery. This could result in the plates not staying securely in place, leading to potential bone displacement or complications during healing.
Patients who have received these specific TN plates during surgery are affected. Surgeons and medical facilities using the recalled plates are at risk of improper bone fixation.
Check for the label 'Orthofix S.r.r. Italy' with part numbers: Small (002-F-01020), Medium (002-F-01025), or Large (002-F-01030). Also look for UDI lots: B1099060, B1099062, or B1099066.
Reach out to Orthofix directly for specific instructions on how to handle the recalled plates.
The recall indicates the locking screws may not properly engage during surgery, so they are not safe for use as described.
Small (002-F-01020), Medium (002-F-01025), and Large (002-F-01030) plates with UDI lots B1099060, B1099062, or B1099066.
The recall does not specify a stop-use instruction; contact Orthofix for details on handling the affected items.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2133-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2133-2018 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.
