Medical Device HIP SCOPE Recall Due to Sterilization Assurance Failure
American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with an inability to confirm sterilization assurance, which represents a significant risk-of-harm for surgical instruments. No illnesses or injuries have been reported, placing this at score 3 per the rubric criteria for risk-of-harm products without documented injury.
Plain-English summary
American Contract Systems Inc is recalling HIP SCOPE surgical instruments (Model Nos. CCHS21B, CCHS21B-01, CCHS21B-02) used in orthopedic hip procedures. A total of 388 kits distributed nationwide in Ohio are affected.
The manufacturer cannot confirm that product sterilization assurance requirements were met. If sterilization was not properly completed or verified, the instruments may not be adequately sterilized.
Unsterilized or inadequately sterilized surgical instruments could increase the risk of infection during hip procedures. Affected lot numbers are 962241, 914241, 70-050890, 70-051579, 70-052206, and 70-053085.
Healthcare facilities and healthcare professionals should not use affected kits. Contact American Contract Systems Inc or the FDA if you have used or dispensed these products.
The recalled product
- Product
- HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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