Reported Dec 27, 2023 · Ongoing
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e)…
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
| Model / number | Product as published |
|---|---|
320-36-00 | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) |
320-36-03 | b) |
320-36-04 | c) |
320-36-10 | d) |
320-36-13 | e) |
320-38-00 | f) |
320-38-13 | g) |
320-40-00 | h) |
320-40-10 | i) |
320-42-00 | j) |
320-42-10 | k) |
320-42-13 | l) |
320-46-10 | m) |
320-46-13 | n) |
- Lot codes and dates
14 of 14 products
Products covered by this recall Model / number Product as published 10885862086617320-36-00, , 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 10885862086624320-36-03, , 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 10885862086624320-36-04, , Serial Numbers: A685325 10885862086631320-36-10, , 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 10885862086648320-36-13, , 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 10885862086655320-38-00, , Serial Numbers: A738779, A738799, A738822, A738823, A738846, A738847, A738848, A738849, A738850 10885862086686320-38-13, , Serial Numbers: A679891 10885862535030320-40-00, , 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 10885862535054320-40-10, , Serial Numbers: A689439, A689441, A689442, A689445, A689448, A689449, A689452, A689453, A689456, A689459, A689461, A689465, A689475, A689476 10885862086693320-42-00, , Serial Numbers: A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989 10885862086716320-42-10, , Serial Numbers: A685535, A685539, A685551, A685557, A685568, A685573 10885862086723320-42-13, , Serial Numbers: A677654, A677663, A677675, A677683, A677690, A677691, A677692, A677698 10885862086754320-46-10, , Serial Numbers: A638847, A638848, A638849, A677703, A677704, A677707, A677708, A677712 10885862086761320-46-13, , Serial Numbers: A662094, A685620, A685624, A685627, A773694, A773700, A773702 - 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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