| | Class 2 Device Recall Exactech Opetrak |  |
| Date Initiated by Firm | November 21, 2023 |
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| Date Posted | January 18, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0582-2024 |
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| Recall Event ID |
93507 |
| 510(K)Number | K160484 K932690 K933610 K954208 |
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| Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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| 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 |
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| 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
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Recalling Firm/
Manufacturer |
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
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| For Additional Information Contact |
352-377-1140 |
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Manufacturer Reason
for Recall | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
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FDA Determined
Cause 2 | Packaging change control |
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| Action | 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. |
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| 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
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
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