| | Class 2 Device Recall Exactech Equinoxe Reverse Shoulder System |  |
| 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-0579-2024 |
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| Recall Event ID |
93507 |
| 510(K)Number | K063569 K093275 K180632 K182536 |
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| Product Classification |
Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
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| 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 |
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| Code Information |
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 |
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 = KWT
510(K)s with Product Code = KWT
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