Recall Z-0585-2024
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
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Codes / lots: a) 02-012-35-3509, GTIN 10885862304346, Serial Numbers: A730624, A730626, A730628, A730630, A730631, A730632, A730633; b) 02-022-35-1509, GTIN 10885862303974, Serial Numbers: A641578, A683756, A683757, A683758, A683759; c) 02-022-35-1513, GTIN 10885862304018, Serial Numbers: A662293; d) 02-022-35-3010, GTIN 10885862304261, Serial Numbers: A662100, A662102, A662104, A662105, A662106, A662107, A662109; e) 02-022-35-3509, GTIN 10885862304346, Serial Numbers: A652047, A652048, A652050, A652052, A652053, A652054, A730952, A730960, A730961; f) 02-022-35-3510, GTIN 10885862304353, Serial Numbers: A662121; g) 02-022-35-3511, GTIN 10885862304360, Serial Numbers: A662301, A662304, A662305; h) 02-022-35-4511, GTIN 10885862304544, Serial Numbers: A684499; i) 02-022-44-3512, GTIN 10885862305206, Serial Numbers: A641603, A641606, A641608, A641612; j) 02-022-47-2509, GTIN 10885862306326, Serial Numbers: A658478, A658486, A702263, A702265, A702267, A702268, A702269, A702271; k) 02-022-51-4519, GTIN 10885862307866, Serial Numbers: A737101, A737106, A737107;
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-0585-2024
- Initiated
- November 21, 2023
- Posted by FDA
- January 18, 2024
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- 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-0577-2024 Class II | AcuMatch Hip System, Catalog Number 142-32-27Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| 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-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 |