Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Recall
- Recall Number
- Z-1425-2024
- Event Number
- 94092
- Firm
- Exactech, Inc.
- FEI Number
- 1038671
- Product Code
- PHX
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 6, 2024
- Posted
- March 29, 2024
- Address
- 2320 Nw 66th Ct, Gainesville, FL, 32653-1630
Description
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
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).
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 [email protected]. 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.
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591 units