Synthes (USA) Products LLC Recall 93924
Description: 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Synthes (USA) Products LLC Recall 93924 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1234-2024 |
| Event ID | 93924 |
| Event Description | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa. |
| Quantity | 5 units |
| Recall Reason | Products not sterilized, sterility cannot be confirmed |
| Device Classification | 20240313 |
| Device Code Info | UDI: 10886982087331 Lot Number: 41P2222 |
| Center Classification Date | 20240301 |
| Recall Initiation Date | 20240124 |
| Recalling Firm | Synthes (USA) Products LLC |
| Initial Notification | |
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