Z-0579-2024Class II

Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d)...

Name: Z-0579-2024 Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d)...
Creator: Exactech, Inc.
Published: 2023-11-21
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2023-11-21 / Open, Classified / root cause: packaging

FDA source

Exactech, Inc. began a recall of Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13... on 2023-11-21. FDA classified it as Class II and gives the reason as "Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0579-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-21
Posted: 2024-01-18
Recalling firm: Exactech, Inc.
Product: Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Root cause tag: packaging
FDA root cause: Packaging change control
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.
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
Product codes and lots: a) 320-36-00, GTIN 10885862086617, Serial Numbers: A641190, A641191, A641194, A641202, A641203, A641215, A641221, A641222, A641223, A641224, A641225, A641228, A641229, A641230, A641232, A641233, A641235, A641237, A641238, A641239, A641240, A641241, A641242, A641244, A641245, A641246, A641247, A680944, A689543, A689544, A689545, A689549, A689553, A689557, A689560, A689565, A689572, A706598, A706612, A706630, A706631, A706639, A706641; b) 320-36-03, GTIN 10885862086624, Serial Numbers: A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A677718, A677727, A677728, A677731, A677732, A677751, A685284, A685289, A685290, A685291, A685292, A685295, A685296, A685298, A685299, A685300, A685301, A685303, A685305, A685306, A685310, A685312, A685315, A685317, A685318, A685319, A685320, A685323, A685326, A685327, A685337, A685338, A685346, A685350, A685351, A685361, A685362, A685363, A685369, A685375, A685377, A685379, A695083, A695088, A695098, A695107, A695120, A695122; c) 320-36-04, GTIN 10885862086624, Serial Numbers: A685325; d) 320-36-10, GTIN 10885862086631, Serial Numbers: A695123, A695124, A695125, A695126, A695127, A695129, A695130, A695131, A695132, A695137, A695140, A695146, A695150, A695151, A695152, A695154, A695155, A695157, A695159, A695160, A695161, A695162, A695165, A695166, A695167, A695168, A716197, A716219, A716230, A716231, A716232, A716233, A716234, A716236; e) 320-36-13, GTIN 10885862086648, Serial Numbers: A696430, A696435, A696436, A696438, A696441, A696443, A696444, A696445, A696446, A696447, A696449, A696450, A696452, A696455, A696458, A696459, A696460, A696461, A696462, A696466, A696469, A696471, A696472, A696473, A696474, A696475, A696477; f) 320-38-00, GTIN 10885862086655, Serial Numbers: A738779, A738799, A738822, A738823, A738846, A738847, A738848, A738849, A738850; g) 320-38-13, GTIN 10885862086686, Serial Numbers: A679891; h) 320-40-00, GTIN 10885862535030, Serial Numbers: A641613, A641619, A641623, A641624, A641626, A641629, A641631, A641632, A688976, A688977, A688981, A688982, A688983, A688984, A688985, A688986, A688989, A688990, A688991, A688992, A688993, A688994, A688997, A688999, A689001, A689002, A689003, A689004, A689008, A689011, A689015, A689016, A689017, A689018, A689019, A689021, A689022, A689023, A689025, A715756, A715757, A715758, A715760, A715762, A715763, A715764, A715766, A715768, A715771, A715775, A750496, A750497, A750499, A750502, A750511, A750524, A750529; i) 320-40-10, GTIN 10885862535054, Serial Numbers: A689439, A689441, A689442, A689445, A689448, A689449, A689452, A689453, A689456, A689459, A689461, A689465, A689475, A689476; j) 320-42-00, GTIN 10885862086693, Serial Numbers: A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989; k) 320-42-10, GTIN 10885862086716, Serial Numbers: A685535, A685539, A685551, A685557, A685568, A685573; l) 320-42-13, GTIN 10885862086723, Serial Numbers: A677654, A677663, A677675, A677683, A677690, A677691, A677692, A677698; m) 320-46-10, GTIN 10885862086754, Serial Numbers: A638847, A638848, A638849, A677703, A677704, A677707, A677708, A677712; n) 320-46-13, GTIN 10885862086761, Serial Numbers: A662094, A685620, A685624, A685627, A773694, A773700, A773702

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0579-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0578-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0579-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0580-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0581-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0582-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0583-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0584-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0585-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0586-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0587-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19
Z-0588-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19

Product code KWT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)