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
- Company
- Exactech, Inc.
- Recall Initiated
- November 21, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0582-2024
- Firm Location
- Gainesville, FL
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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
Lot / Code Info
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
Root 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.