Waldemar Link GmbH & Co. KG (Mfg Site) Recall 92758
Description: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
Waldemar Link GmbH & Co. KG (Mfg Site) Recall 92758 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2345-2023 |
| Event ID | 92758 |
| Event Description | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 14 units |
| Recall Reason | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue |
| Device Classification | 20230816 |
| Device Code Info | UDI-DI: 04026575182084 Lot Numbers: B923005 B932048 |
| Center Classification Date | 20230804 |
| Recall Initiation Date | 20230703 |
| Recalling Firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Initial Notification | |
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