Alto Development Corp recalls Thorecon Plating System Kits Model 94-1500-04-S for sternum fracture fixation due to a molding defect causing tensioners to be 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 is recalling Thorecon Plating System Kits Model 94-1500-04-S used for sternum fracture fixation. The kits contain 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 tensioner unable to function properly. This could result in inadequate bone fixation during surgery.
Patients undergoing sternum fracture repair or reconstruction are likely affected. Surgeons and medical facilities using these kits are at risk of improper bone fixation.
Check for the model number 94-1500-04-S on the kit packaging. These kits were sold for sternum fracture fixation procedures.
Verify the model number on the kit packaging to confirm if it is 94-1500-04-S.
The Thorecon disposable tensioners in these kits have a molding defect that blocks the cable tensioning channel, making them inoperable.
The tensioners may not function properly, potentially leading to inadequate bone fixation during sternum fracture repair.
Look for the model number 94-1500-04-S on the kit packaging. These kits are used for sternum fracture fixation.
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-0245-2020 — Alto Development Corp Alto Development Corp Hello, I own a Alto Development Corp that is covered by recall Z-0245-2020 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.
