Recall Z-0577-2024
Exactech, Inc. · initiated November 21, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AcuMatch Hip System, Catalog Number 142-32-27
Codes / lots: GTIN 10885862538192, Serial Numbers: A673200, A673204, A673209
Reason for recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA-determined cause: Packaging change control
Action taken
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.
Details
- Recall number
- Z-0577-2024
- Initiated
- November 21, 2023
- Posted by FDA
- January 18, 2024
- Product code
- OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- 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
- Recalling firm
- Exactech, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0578-2024 Class II | Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0579-2024 Class II | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0580-2024 Class II | Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0581-2024 Class II | Exactech Novation Hip System, Catalog Numbers: 134-36-45Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0582-2024 Class II | Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0583-2024 Class II | Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0584-2024 Class II | Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0585-2024 Class II | Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0586-2024 Class II | Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0587-2024 Class II | Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0588-2024 Class II | Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |