Orthopedic ORIF Hip Rod Procedure Kit Recalled for Sterilization Residuals
American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.
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 an FDA Class II medical device recall involving chemical residuals exceeding safe limits in a permanent implant. Although no illnesses or injuries have been reported, the device poses a risk of harm due to chemical exposure over the lifetime of the implant, meeting the rubric criterion for High severity.
Plain-English summary
American Contract Systems Inc is recalling the ORIF HIP IM RODDING FEMUR-Procedure Kit due to ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals in the cast padding component that exceed the established safety limits for permanent medical devices. The recalled kits contain 28 units with lot numbers 639231 and 936241 (UDI-DI: 00191072154934) and were distributed nationwide in the United States.
Ethylene oxide is a sterilization agent used to eliminate bacteria and other microorganisms from medical devices. However, residual ethylene oxide and its by-product ethylene chlorohydrin must be reduced to safe levels, particularly in devices that remain implanted long-term. The residuals in the cast padding component of this kit exceeded the limits specified in the ANSI/AAMI/ISO 10993-7:(R)2012 standard for permanent-contact devices.
No illnesses or injuries related to this issue have been reported to date. Patients who have received implants from these lots should consult their healthcare provider for guidance. Healthcare facilities should quarantine any remaining inventory and contact the manufacturer for return or replacement instructions.
The recalled product
- Product
- ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide
- sterilization-residuals
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: 00191072154934 LOT#"s: 639231 936241
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27