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Equinoxe recallZ-1425-2024 · Exactech, Inc. · initiated Mar 6, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

FDA root cause category: Nonconforming Material/Component

What the company is doing

Beginning 03/06/2024, Exactech issued an URGENT MEDICAL DEVICE RECALL notice and an URGENT DEAR HEALTHCARE PROFESSIONAL COMMUNICATION to its consignees via email. The recall notice explained the issue, clinical impact, and requested the following actions be taken: "" CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. " IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customer s inventory listed Product Scope Listing. " EXTEND THE DESCRIPTION OF ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. " COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at [email protected]. The communication to healthcare providers referenced the FDA Safety Communication issued on 01/16/2024, explained the issue, potential health risks, and suggested patient monitoring for those with implanted affected devices for potential device wear, failure, or bone loss and should consider performing X-rays to further evaluate the patient and their implanted device if you suspect a failed device. Contact your local Exactech Representative if you have any questions regarding this communication.

Recall details

Recall number
Z-1425-2024
Status
Open, Classified
Initiated by the company
Mar 6, 2024
Posted by the FDA
Mar 29, 2024
Recalling firm
Exactech, Inc.
Quantity
591 units
Product code
PHX
FDA submissions
K063569
Distribution
Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

Product description

Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

a) Item number 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091, 1018097, 1018084, 0984530, 0984547, 0984529, 0984532, 1332742, 1361390, 1545622, 1545624, 1361388, 1466508, 1466510, 1466513, 1466514, 1469127, 1466511, 1469130, 1683551, 1683520, 1683540, 1683541, 1683545, 1683548, 1683552, 1683554, 1683557, 1683515, 1332737, 1469126, 2010727, 1683514, 1683532, 1683529, 1683536, 2118729, 2118731, 2104263, 2118733, 2118732, 0984535, 1332736, 1361392, 1683527, 2010723, 1683558, 2010721, 1683523, 1683528, 2194597, 2265086, 2296247, 2296249, 2104265, 2265088, 2394874, 2394872, 2104261, 2151089, 2427260, 2427269, 2296245, 2532045, 2394871, 2296262, 2532055, 2151096, 2265081, 2532038, 2532065, 2532066, 2532061, 1466512, 1683556, 1683531, 2194603, 2427272, 2151091, 2532054, 2532053, 2532037, 2532044, 3533621, 2847727, 2847735, 1683544, 1683524, 2118730, 2104264, 2532058, 2194598, 2265090, 2532059, 2532052, 2532048, 2532035, 2532057, 2532060, 2532050, 2394868, 2847740, 2847747, 2847731, 3645487, 3905359, 3905367, 2427262, 2427264, 2532063, 2847737, 3533628, 4341764, 4341770, 3905370, 3905361, 4341771, 4426302, 4426303, 4426306, 4426308, 4426301, 3905383, 3645478, 2847744, 2847725, 3645475, 3645479, 3825547, 3825543, 4426305, 4426318, 4426313, 4341756, 4341762, 4769063, 4857596, 4719181, 4805400, 5076014, 5013622, 5013621, 4805392, 4719182, 4857595, 4944150, 4944152, 4857603, 4805402, 5076021, 5013616, 5013637, 4944148, 3533623, 2847746, 4341760, 3825534, 3905360, 4341758, 3905374, 3905373, 4769064, 4944159, 4803379, 4805406, 5013632, 5044684, 5013615, 5013635, 4944154, 4805401, 4857600, 4769070, 5165732, 5165740, 5165745, 5044679, 3825535, 3905377, 3825538, 3825551, 4805382, 5044682, 5013626, 5165747, 5076023, 4944168, 4805379, 4805381, 4805384, 5165757, 5867596, 6271755, 6271759, 5867598, 5867608, 4426309, 4805385, 4944149, 5165756, 5013628, 5165752, 4944161, 5013617, 6347991, 5867602, 6271743, 6271750, 6271742, 6347969, 6594357, 4944163, 5013620, 4857593, 4769073, 5076013, 4857604, 4857606, 4756178, 4719185, 6271751, 6271744, 6271762, 6271746, 6594355, 5013633, 5044690, 6347990, 5867583, 5867590, 6347997, 5867593, 6347968, 6271763, 6594360, 6347988, 5867601, 5867594, 6347970, 6594353, 6594359, 6594345, 6271760, 6594343; b) Item Number 320-46-13, UDI/DI 10885862086761, Serial Numbers: 0983443, 0983412, 0983426, 0983423, 0983430, 1069733, 1069752, 1069781, 1069734, 0983434, 0983417, 1069736, 1069735, 0983425, 0983442, 0983427, 1069757, 0983414, 0983419, 0983435, 1069761, 1069773, 1069738, 1069740, 1069747, 1490759, 1490757, 1490762, 1490753, 1546325, 1069770, 1069767, 1490755, 1546322, 1546323, 1546326, 1802197, 1686810, 1802204, 1802901, 1686806, 1686816, 1686821, 1802200, 1802902, 1802904, 1802198, 1686811, 1802196, 1069776, 1069765, 0983436, 1069777, 1490758, 1990103, 1917844, 2027971, 1939803, 1802201, 2027968, 2027972, 2108016, 2108017, 2108013, 1990105, 1686805, 1939802, 2229147, 2132339, 2296907, 2296898, 2296901, 2296911, 2131629, 2229137, 2296897, 2392588, 2392596, 2392600, 2418293, 1546324, 2296905, 2229143, 2131627, 2513181, 2392587, 2418290, 2513173, 2296904, 2296899, 2296888, 2392593, 2392605, 2505459, 2392594, 1802205, 1686812, 1686824, 2505455, 2296908, 2296915, 2296891, 2173989, 2513193, 2418281, 2513179, 2392598, 2513188, 2513183, 2252628, 2513195, 2229150, 2513176, 2834933, 2834945, 2834957, 2834946, 2834947, 1990104, 1939806, 1990101, 2229141, 2513175, 2296889, 2132336, 2513185, 2513186, 2505457, 2296919, 2418278, 2173987, 2418292, 2296900, 2513184, 2131626, 2513190, 2988513, 2988494, 2988514, 2988509, 2795053, 2795052, 2795051, 2795054, 2988503, 2988518, 3901534, 3901529, 3901531, 4115341, 3901523, 2418286, 2392599, 2296892, 2418285, 2513177, 2513172, 2513191, 2132334, 2834934, 2988507, 2834953, 2834939, 2795050, 3901513, 3901528, 3886029, 4115340, 4309970, 4387134, 4127396, 4127400, 4309979, 3901521, 2988521, 2988510, 3901512, 4387118, 4309977, 4127406, 4387116, 4127402, 3901519, 4309976, 4703255, 4963999, 4827125, 4788000, 4827130, 4827145, 4977223, 5027773, 4902312, 5074892, 4902309, 4703261, 4703258, 4703253, 5017482, 4902313, 4827135, 4902311, 4827131, 4827142, 2988497, 2988515, 4309969, 4387131, 4127404, 4309981, 3901530, 4387122, 4127398, 4827120, 4846562, 5017483, 4801490, 4703262, 4827144, 4788001, 5049876, 4977228, 5150219, 4975984, 5027775, 5062075, 4788003, 5207482, 4769028, 4780644, 4691479, 4703266, 5150207, 5150210, 5207471, 4703248, 2988519, 3901520, 3901525, 4115338, 3886033, 4387113, 4387114, 3886028, 4309974, 3901526, 4780641, 5150211, 5017481, 4801495, 4703264, 5074890, 5207476, 5207478, 5207472, 5207480, 4827132, 4691475, 6164395, 5874286, 5874267, 5874265, 6164414, 5874264, 4309968, 4127417, 4127403, 5017485, 5150201, 5062077, 5062083, 4964000, 5027774, 4975985, 4827133, 5874273, 5874260, 6164394, 5874280, 5874281, 5874287, 6164421, 5874270, 5874283, 5874262, 6709483, 4387130, 4309966, 5049878, 5150217, 4827146, 4902315, 4703269, 4703260, 5074891, 5150209, 4780643, 6164401, 5874284, 5874277, 6164405, 6356447, 6164409, 6709485, 6593476, 6593475, 6709475, 6593467, 6709500, 5150220, 5074889, 4975981, 4977225, 6164397, 6356450, 6164399, 6593480, 6593491, 6593486, 6593459, 6709465, 6709481, 6593471, 6709472, 6709484, 6356435, 6164422, 5874274, 6164410, 6356437, 6356434, 6164408, 6593478, 6709493, 6593474, 6593485, 6593473, 6709489, 6593457, 6709468, 6709491, 6164412

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

43 devices cleared under K063569 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94092).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page