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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 388
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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