Orthofix recalls sterile L-Plate surgical plates due to locking screws failing to engage during surgery. 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 L-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 if the plates are used without the screws properly securing them.
The locking screws in the L-Plates may not securely attach to the plates during surgery. This could result in the plates not holding bones together correctly, potentially causing the fracture to not heal properly or requiring additional surgery.
Surgical patients who received the recalled L-Plates during procedures. Medical professionals using these plates for bone fixation are most at risk if the screws fail to engage properly.
Check for the part numbers: Left (003-E-00001L) or Right (003-E-00001R). Look for UDI lots: B1108952 or B1108955. These plates are sold under the brand Orthofix.
Reach out to Orthofix directly for specific instructions on how to handle the recalled plates.
The recall is happening because the locking screws may not properly engage with the plates during surgery, which could lead to improper bone fixation.
Contact Orthofix directly for specific instructions on how to handle the recalled plates.
Yes, if the screws don't engage properly, the plates may not hold bones together correctly, potentially requiring additional surgery.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2130-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2130-2018 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.
