Alto Development Corp recalls Thorecon Plating System Kits Model 94-1300-04-S for sternum fracture fixation due to defective tensioners that may not function properly.
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 94-1300-04-S used for sternum fracture repair because some tensioners have a defect that makes them inoperable. This could lead to improper bone fixation if used.
The tensioners have a molding defect that blocks the cable channel, preventing them from adjusting tension properly. This could result in improper bone fixation during surgery.
Patients undergoing sternum fracture repair with the recalled Thorecon Plating System Kits are affected. Surgeons and medical staff using these kits for procedures are at risk.
Check for the model number 94-1300-04-S on the kit packaging or label. The kits are used for sternum fracture fixation and were sold with serial numbers 327703, 327704, 330464, and 344282.
Look for the model number 94-1300-04-S on the kit packaging or label.
Some Thorecon disposable tensioners in these kits have a molding defect that blocks the cable channel, making them inoperable for bone fixation.
The official recall notice does not specify a remedy or action steps for affected users.
The affected model numbers are 94-1300-04-S with serial numbers 327703, 327704, 330464, and 344282.
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-0243-2020 — Alto Development Corp Alto Development Corp Hello, I own a Alto Development Corp that is covered by recall Z-0243-2020 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.
