FDA Device recall Z-2355-2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects… by Waldemar Link And Kg Mfg Site, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2355-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-03 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
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
Identifiers
| code_info | UDI-DI: 04026575182183 Lot Numbers: B922115 B933170 C005042 C211018 C240049 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2355-2023%22
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