CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Equinoxe Shoulder System recalled by Exactech
Exactech is recalling Exactech Equinoxe Shoulder System, distributed in 16 states. The recall was initiated on 21 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0580-2024
- FDA event ID
- 93507
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Nov 2023
- FDA classified
- 19 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Nov 2023 | Recall initiated by company | |
| 19 Dec 2023 | Classified by FDA | +28 days |
| 27 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Product as listed by the FDA
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
Where it was distributed
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
ArkansasFloridaGeorgiaIllinoisIndianaKentuckyMarylandMaineMinnesotaNew HampshireNevadaNew YorkSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Is Equinoxe Shoulder System recalled?
Yes. Exactech recalled Equinoxe Shoulder System on 21 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0580-2024.
Why was it recalled?
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Which lots are affected?
a) 314-23-02, GTIN 10885862585288, Serial Numbers: A644041, A644042, A644043, A644044, A660121, A660122, A660124, A662676, A662681, A662684, A662685, A662688, A680284, A680285, A680288, A680289; b) 314-23-03, GTIN 10885862585295, Serial Numbers: A705013, A705015, A705017, A705019, A724643, A724644, A724645, A724649, A724650, A724653, A724654, A724655, A724660, A724662, A724664; c) 314-23-13, GTIN 10885862585318, Serial Numbers: A641342, A641343, A641348, A659643, A659645, A662713, A662714, A662715, A662716, A662717, A662718, A662722, A662728, A724502, A724505, A724509, A724512, A724519, A724520, A724521, A724522, A724529, A724531, A724535, A724542, A737352, A737356; d) 314-23-14, GTIN 10885862585325, Serial Numbers: A644055, A644056, A644057, A649227, A649231, A659611, A662730, A662731, A662732, A662733, A662734, A662736, A662737, A662743, A662744, A662745, A737404, A737408; e) 314-23-15, GTIN 10885862585332, Serial Numbers: A644011, A644012, A644013, A644015, A649151, A649157, A649158, A649160, A649161, A649162, A649164, A649165, A659613, A659614, A659615, A659616, A659617, A659620, A659622; f) 314-24-22, GTIN 10885862585349, Serial Numbers: A662708, A704921, A704924, A708554, A708559, A708560, A737109, A737114, A737115, A737117; g) 314-24-23, GTIN 10885862585356, Serial Numbers: A680327, A704932, A704936, A704939, A704941, A704943, A704945; h) 314-24-24, GTIN 10885862585363, Serial Numbers: A697922, A697923, A697928, A704996, A704997, A704998, A704999, A705000, A705001, A705002, A705003, A705004, A705005, A705007, A705009, A705011, A737098; i) 314-24-32, GTIN 10885862585387, Serial Numbers: A660114, A691515, A691522, A708328; j) 314-24-33, GTIN 10885862585394, Serial Numbers: A660130, A660135, A660137, A660139, A660140, A704661, A704662, A704665, A704667; k) 314-24-34, GTIN 10885862585400, Serial Numbers: A649166, A649168, A649169, A649170, A649175, A662702; l) 314-24-35, GTIN 10885862585417, Serial Numbers: A659658, A659663
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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