Recall Z-1415-2024 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
| Date | Mar 29, 2024 (initiated Mar 6, 2024) |
| Status | Open, Classified |
| 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 CLI |
| Quantity | 4007 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113309 | EXACTECH EQUINOXE CAGE GLENOIDS Exactech, Inc., Dec 8, 2011 |