Exactech Optetrak Knee System – Vacuum Bag Loss (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Exactech, Inc. is recalling Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 20 due to Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, FL, GA, IL, IN, KY, ME, MD, MN, NV, NH, NY, SC, TN, TX, VA
Page updated: Jan 10, 2026