FDA Recall
Open, Classified
AcuMatch Hip System, Catalog Number 142-32-27
Recall: Z-0577-2024
·
Initiated November 21, 2023
Recall
- Recall Number
- Z-0577-2024
- Event Number
- 93507
- Firm
- Exactech, Inc.
- FEI Number
- 1038671
- Product Code
- OQI
- Status
- Open, Classified
- Root Cause
- Packaging change control
- Initiated
- November 21, 2023
- Posted
- January 18, 2024
- Address
- 2320 Nw 66th Ct, Gainesville, FL, 32653-1630
Description
AcuMatch Hip System, Catalog Number 142-32-27
Reason
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Action
Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
Distribution
US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK