Exactech, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1408-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty

Product Classification:

Class II

Date Initiated: March 6, 2024

Date Posted: April 10, 2024

Recall Number: Z-1408-2024

Event ID: 94092

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).

Status: Ongoing

Product Quantity: 35 units

Code Information:

a) Item Number 314-04-22, UDI/DI 10885862199553, Serial Numbers: 2111946, 2136867, 2136870, 2427405; b) Item Number 314-04-23, UDI/DI 10885862199560, Serial Numbers: 2111953, 2111954, 2139294, 2111955, 2139292, 2139291, 2139288, 2139290, 2424307, 2424304, 2111952, 2424306, 2424314, 2424305, 2482942; c) Item Number 314-04-24, UDI/DI 10885862199577, Serial Numbers: 2111949, 2111950, 2153613, 2153608, 2153607, 2153611, 2153612, 2421997, 2153609, 2421992, 2111951, 2153610, 2421994; d) Item Number 314-04-25, UDI/DI 10885862199584, Serial Numbers: 2112018, 2112019, 2427567

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated