Alto Development Corp recalls Thorecon Plating System Kits Model 94-1700-10 for sternum fracture fixation due to molding defect making tensioners inoperable. Affected units include specific model numbers listed.
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
Alto Development Corp is recalling Thorecon Plating System Kits Model 94-1700-10 used for sternum fracture fixation because some units have a molding defect that makes the tensioner inoperable. This could lead to improper bone fixation if used.
The molding defect blocks the cable tensioning channel, so the tensioner cannot function properly. This means the device may not hold bones together correctly during surgery, potentially leading to improper healing.
Orthopedic surgeons and medical professionals who use these kits for sternum fracture repair are most at risk. Patients receiving this specific model for surgery may also be affected.
Check for model numbers 94-1700-10 on the kit packaging or label. These kits are used for sternum fracture fixation and were sold with specific serial numbers listed in the recall.
Look for model number 94-1700-10 on the kit packaging or label.
Some Thorecon disposable tensioners in these kits have a molding defect that blocks the cable tensioning channel, making the tensioner inoperable.
The tensioner may not function properly, which could lead to improper bone fixation during sternum fracture repair.
Check for model number 94-1700-10 on the kit packaging or label. Affected kits include specific serial numbers listed in the recall.
We’ve drafted a message you can send Alto Development Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-0246-2020 — Alto Development Corp Alto Development Corp Hello, I own a Alto Development Corp that is covered by recall Z-0246-2020 from Alto Development Corp. 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.
