American Contract Systems recalls Total Hip Pack models SMTH06O and SMTH06P due to possible sterilization issues causing treatment delays. Affected units sold between 2005-2:05 and 2005-05.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling Total Hip Pack surgical devices because they may not have been properly sterilized, which could cause treatment delays or complications. This affects patients who received these specific models during the listed production periods.
The devices may not have been properly sterilized, which could lead to treatment delays or complications. This is a risk during surgical procedures where the device is used to hold the hip joint in place.
Patients who received Total Hip Pack models SMTH06O or SMTH06P during production runs from 2005-05 to 2005-05 are most at risk. Healthcare providers using these models for surgical procedures may also be affected.
Check for model numbers SMTH06O or SMTH06P on the device. The product was sold between 2005-05 and 2005-05 with specific lot numbers listed in the recall notice.
Look for model numbers SMTH06O or SMTH06P on the device to confirm if it's affected.
American Contract Systems is unable to confirm product sterilization assurance requirements were met, which could lead to treatment delays or complications.
Check the model number on the device. If it's SMTH06O or SMTH06P, contact American Contract Systems for further instructions.
The product was sold between 2005-05 and 2005-05 with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1347-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1347-2025 from American Contract Systems. 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.
