OrthoPediatrics recalls 6.0MM spine rods with incorrect laser etching that could lead to unintended fractures. Affected models include 00-1300-6053 (Lot 108332-A).
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
OrthoPediatrics is recalling 6.0MM spine rods that may have incorrect laser etching, which could weaken the device and cause unintended fractures. This is serious for patients using the rods for spinal stabilization.
The rod may have incorrect laser etched alignment lines, which can compromise its structural strength. This weakness might lead to unintended fractures during spinal stabilization procedures.
Skeletally mature patients using the OrthoPediatrics 6.0MM spine rod for spinal stabilization. Those with the specific model number 00-1300-6053 and lot number 108332-A are most at risk.
Check for model number 00-1300-6053 and lot number 108332-A on the product. The device is intended for immobilization of the non-cervical spine in skeletally mature patients.
Look for model number 00-1300-6053 and lot number 108332-A on the device.
The product may have incorrect laser etching that could lead to unintended fractures, so it is not safe to use without checking for the specific model and lot numbers.
The recall record does not specify a remedy, so you should check the product details and contact OrthoPediatrics if you have the model number 00-1300-6053 and lot number 108332-A.
Check for model number 00-1300-6053 and lot number 108332-A on the device. The product is intended for spinal stabilization in skeletally mature patients.
We’ve drafted a message you can send OrthoPediatrics to request your refund or repair — edit it as you like.
Subject: Recall Z-2742-2020 — OrthoPediatrics OrthoPediatrics Hello, I own a OrthoPediatrics that is covered by recall Z-2742-2020 from OrthoPediatrics. 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.
