Recall Z-0582-2024
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 Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
Codes / lots: a) 200-02-26, GTIN 10885862039576, Serial Numbers: A736412; b) 200-02-29, GTIN 10885862039583, Serial Numbers: A689481, A689501, A689515, A708024, A708032, A708035, A708038, A708050, A708077, A708082, A708092, A708100, A708111; c) 200-02-32, GTIN 10885862039590, Serial Numbers: A679528, A679530, A679539, A679547, A679550, A684414, A715781, A715800, A715804, A715824, A715828, A715924; d) 200-02-35, GTIN 10885862039606, Serial Numbers: A661377, A661380, A661381, A661391, A661395; e) 200-02-38, GTIN 10885862039613, Serial Numbers: A708298, A708300, A708301, A708304, A708316, A708320, A708324; f) 200-02-41, GTIN 10885862039620, Serial Numbers: A665568, A665569, A665575, A665578, A665581, A665582, A665584, A665585, A665586, A665588, A665592, A699428, A699429, A699433, A699437, A699444, A699449, A699450, A699455; g) 200-03-32, GTIN 10885862039651, Serial Numbers: A773440, A773441, A773470; h) 200-07-29, GTIN 10885862314277, Serial Numbers: A656015, A656020, A656022, A656026, A656030, A656031, A656032, A656033, A656035, A656038, A679488, A679495, A679498, A679508, A679516; i) 200-07-32, GTIN 10885862314284, Serial Numbers: A664708, A680022, A680031, A680034, A680039, A680041, A680044…
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-0582-2024
- 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-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 |