Alto Development Corp recalls Thorecon Plating System Kits Model 94-1200-08 for sternum fracture fixation due to a molding defect that makes tensioners inoperable.
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 recalls Thorecon Plating System Kits Model 94-1200-08 for sternum fracture fixation. The kits have a molding defect that makes the tensioners inoperable, which could lead to improper bone fixation.
The molding defect blocks the cable tensioning channel, making the tensioners unable to function properly. This could result in improper bone fixation during sternum surgery.
Medical professionals who use these kits for sternum fracture fixation are affected. Patients receiving this treatment may be at risk if the tensioners fail.
Check for the model number 94-1200-08 on the kit packaging or label. These kits were sold with serial numbers 327122, 327752, 328826, 328913, and 334394.
Verify the model number on the kit packaging or label to confirm if it is 94-1200-08.
The Thorecon disposable tensioners in these kits have a molding defect that blocks the cable tensioning channel, making them inoperable.
Check the model number on the kit packaging or label. If it is 94-1200-08, contact Alto Development Corp for further instructions.
The inoperable tensioners could lead to improper bone fixation during sternum surgery, but the recall is for medical use only.
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-0242-2020 — Alto Development Corp Alto Development Corp Hello, I own a Alto Development Corp that is covered by recall Z-0242-2020 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.
