Exactech, Inc.: Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

Recall number

Z-1409-2024

Recalling firm

Exactech, Inc.

Product

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

Status

Open, Classified

Initiated

2024-03-06

Posted

2024-03-29

Terminated

not on file

Reason

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).

Root cause

Nonconforming Material/Component

Action

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 recalls@exac.com. 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.

Quantity

39 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

Lot, serial or model codes

a) Item Number 314-04-32, UDI/DI 10885862199553, Serial Numbers: 2111957, 2161636, 2111956, 2161639, 3755661; b) Item Number 314-04-33, UDI/DI 10885862199560, Serial Numbers: 2112015, 2112016, 2112013, 2112014, 2136760, 2136755, 2424239, 2424237, 2136756, 2424241, 2712715, 3892095, 3892094; c) Item Number 314-04-34, UDI/DI 10885862199577, Serial Numbers: 2111987, 2111986, 2111984, 2138759, 2138757, 2138754, 2138756, 2138755, 2138753, 2425638, 2485901, 2425634, 2138758, 2111985, 2425636, 2425629, 2425627, 2425625; d) Item Number 314-04-35, UDI/DI 10885862199584, Serial Numbers: 2111991, 2430293, 2430292

510(k) numbers

["K111379"]

PMA numbers

not on file

Product code

KWS

Firm FEI

1038671

Firm city

Gainesville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy