Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LE

Recalled Product

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LE

Get the next US recall alert before it hits the news.