Z-0582-2024 Class II Ongoing
FDA device recall Z-0582-2024 was initiated by Exactech, Inc. on November 21, 2023 and is designated Class II. Reason for recall: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Distribution Pattern
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
Code Information
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, A680049, A680071, A680072, A680073; j) 200-07-35, GTIN 10885862314291, Serial Numbers: A655621, A655637, A655640, A655641, A655656, A655657, A655659, A655667, A655676, A679417, A679418, A679421, A679453, A679462, A681114, A681132, A681135; k) 204-21-13, GTIN 10885862048165, Serial Numbers: A679949; l) 204-22-26, GTIN 10885862048288, Serial Numbers: A770137; m) 208-23-18, GTIN 10885862054289, Serial Numbers: A655685, A655691; n) 208-24-13, GTIN 10885862054340, Serial Numbers: A655589