Exactech, Inc. Recall 94092
Description: 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
Exactech, Inc. Recall 94092 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1409-2024 |
| Event ID | 94092 |
| Event Description | 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 |
| Product Type | Devices |
| 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 |
| Quantity | 39 units |
| Recall 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). |
| Device Classification | 20240410 |
| Device Code Info | 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 |
| Center Classification Date | 20240329 |
| Recall Initiation Date | 20240306 |
| Recalling Firm | Exactech, Inc. |
| Initial Notification | Letter |
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