Reported Dec 27, 2023 · Ongoing

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,…

Exactech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630

Is this the product you have?

14 of 14 products

Products covered by this recall
Model / numberProduct as published
200-02-26Exactech Optetrak Knee System, Catalog Numbers: a)
200-02-29b)
200-02-32c)
200-02-35d)
200-02-38e)
200-02-41f)
200-03-32g)
200-07-29h)
200-07-32i)
200-07-35j)
204-21-13k)
204-22-26l)
208-23-18m)
208-24-13n)
Lot codes and dates

14 of 14 products

Products covered by this recall
Model / numberProduct as published
10885862039576200-02-26, , Serial Numbers: A736412
10885862039583200-02-29, , Serial Numbers: A689481, A689501, A689515, A708024, A708032, A708035, A708038, A708050, A708077, A708082, A708092, A708100, A708111
10885862039590200-02-32, , Serial Numbers: A679528, A679530, A679539, A679547, A679550, A684414, A715781, A715800, A715804, A715824, A715828, A715924
10885862039606200-02-35, , Serial Numbers: A661377, A661380, A661381, A661391, A661395
10885862039613200-02-38, , Serial Numbers: A708298, A708300, A708301, A708304, A708316, A708320, A708324
10885862039620200-02-41, , Serial Numbers: A665568, A665569, A665575, A665578, A665581, A665582, A665584, A665585, A665586, A665588, A665592, A699428, A699429, A699433, A699437, A699444, A699449, A699450, A699455
10885862039651200-03-32, , Serial Numbers: A773440, A773441, A773470
10885862314277200-07-29, , Serial Numbers: A656015, A656020, A656022, A656026, A656030, A656031, A656032, A656033, A656035, A656038, A679488, A679495, A679498, A679508, A679516
10885862314284200-07-32, , Serial Numbers: A664708, A680022, A680031, A680034, A680039, A680041, A680044, A680049, A680071, A680072, A680073
10885862314291200-07-35, , Serial Numbers: A655621, A655637, A655640, A655641, A655656, A655657, A655659, A655667, A655676, A679417, A679418, A679421, A679453, A679462, A681114, A681132, A681135
10885862048165204-21-13, , Serial Numbers: A679949
10885862048288204-22-26, , Serial Numbers: A770137
10885862054289208-23-18, , Serial Numbers: A655685, A655691
10885862054340208-24-13, , Serial Numbers: A655589
Amount recalled
N/A

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.