Exactech Equinoxe GLENOID recall
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number…
Why was Exactech Equinoxe GLENOID 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) Item Number 314-06-22, UDI/DI 10885862228307, Serial Numbers: 2579212, 2634987, 2635008, 2579195, 2579206, 2811940, 2811957, 2811935, 2634983, 5718616, 5718644, 5718619, 5933499, 5933502, 5704955, 6756450, 6756452, 5718637, 5933505, 6756441, 6756445, 6756449, 6756455, 5933325, 5933336, 6756451; b) Item Number 314-06-23, UDI/DI 10885862228314, Serial Numbers: 2579171, 2579188, 2635070, 2635068, 2579173, 2635067, 2635101, 2635061, 2635071, 2635064, 2823506, 2823492, 2579179, 2579187, 2635077, 2635078, 2635079, 2635082, 2579172, 4209444, 4209441, 3810131, 2823487, 2811883, 2635086, 2635100, 4209447, 2823504, 2823511, 2635057, 4209454, 3810133, 5247720, 5247712, 5247733, 4209436, 4209451, 5244109, 5247721, 5244110, 5369572, 5600215, 5600216, 5679291, 5369568, 5369563, 5247729, 5369582, 5369569, 5369570, 5369562, 6195298, 5929433, 6611524, 6611529, 6237444, 6195311, 5369578, 5369577, 5369564, 5583201, 6611525, 6611527, 6611530, 6611532, 6237443, 6237446, 6237448; c) Item Number 314-06-24, UDI/DI 10885862228321, Serial Numbers: 2635040, 2579234, 2635025, 2816589, 2816585, 2579228, 2579235, 2579229, 2635020, 2635050, 2635032, 2635039, 2816586, 2823519, 2816606, 2823524, 2579225, 2635016, 2579220, 2635029, 2635047, 2579215, 2816588, 2635035, 2816625, 3876622, 2823533, 2816613, 2823521, 5305367, 5305350, 5600031, 5554824, 5554813, 4209480, 4209466, 3794397, 5305372, 5305361, 5305349, 5753670, 5753659, 5305368, 5554812, 6006578, 5583280, 5305370, 5368871, 5554819, 6006580, 6195255, 6195269, 5753671, 6006579, 6006584, 6612218, 6612226, 6612228, 6612229, 6418445, 6418448, 6612220, 6612222, 6006569, 6195273, 6418446; d) Item Number 314-06-25, UDI/DI 10885862228338, Serial Numbers: 2579243, 2579239, 2823562, 2618355, 2618388, 2618360, 2618398, 3810139, 5718648, 5301843, 5258719, 5730095, 5730085, 6534089, 6534098, 6037827, 6534084, 6534088, 6060453, 6534086
- Product
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number…
- Recalling firm
- Exactech, Inc.
- Quantity
- 180 units
- 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
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)