Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
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 an FDA Class II recall of a risk-of-harm medical device where no illnesses or injuries have been reported. The potential for sterilization failure leading to device malfunction and treatment delay qualifies it as High severity per the recall rubric.
Plain-English summary
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P because the manufacturer is unable to confirm that sterilization assurance requirements were met.
Sterilization assurance is critical for medical implants. The manufacturer stated that possible loss or lack of functionality may lead to delay or prolonged treatment for patients.
The recalled products consist of 24 kits distributed in Ohio. If you have received one of these implants, speak with your healthcare provider for guidance.
The recalled product
- Product
- TOTAL HIP PACK , Model No SMTH06O SMTH06P
- Manufacturer
- American Contract Systems Inc
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00191072163882 00191072229601 Lots 969241 928241 70-051508 70-052517
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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