🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: March 6, 2024 Exactech Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Exactech, Inc.
Reason for Recall:
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1410-2024

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