Exactech Novation Hip System Recalled for Vacuum Seal Loss
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
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: The recall involves an FDA Class II device with no reported hospitalizations, injuries, or illnesses. This is a risk-of-harm product (orthopedic implant) where a manufacturing defect has been identified but no patient harm has been documented, warranting a High severity score per the rubric.
Plain-English summary
Exactech, Inc. is recalling the Novation Hip System (Catalog Number 134-36-45) due to loss of vacuum in the inner-most vacuum bag of the sterile packaging.
The loss of vacuum may affect the integrity of the sterile package and the device. The company has received 3 complaints related to this defect affecting 4 devices.
Affected serial numbers are A763009, A763010, A763011, A763017, A763018, and A763020. The devices were distributed to healthcare facilities in multiple U.S. states including New York, Texas, Indiana, Illinois, Minnesota, Kentucky, Virginia, Maryland, Tennessee, Georgia, New Hampshire, Maine, South Carolina, Nevada, Florida, and Arkansas, as well as internationally to Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom.
Patients or healthcare professionals who have questions about this recall should contact Exactech, Inc. for further information and guidance.
The recalled product
- Product
- Exactech Novation Hip System, Catalog Numbers: 134-36-45
- Manufacturer
- Exactech, Inc.
- Hazard
- device-failure
- vacuum-seal-loss
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 (7)
- GTIN 10885862024046
- Serial Numbers: A763009
- A763010
- A763011
- A763017
- A763018
- A763020
Distribution
Distributed in 16 states:
- AR
- FL
- GA
- IL
- IN
- KY
- MD
- ME
- MN
- NH
- NV
- NY
- SC
- TN
- TX
- VA
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