FDA Device recall Z-1296-2024
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
- FDA Device
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented by Waldemar Link And Kg Mfg Site, citing due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1296-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-06 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
Product
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Reason
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Identifiers
| code_info | Product Code (UDI/DI): 127-610/17 (04026575387168) , 127-610/26 (04026575387304) , 127-610/35 (04026575387441), 127-612…Product Code (UDI/DI): 127-610/17 (04026575387168) , 127-610/26 (04026575387304) , 127-610/35 (04026575387441), 127-612/17 (04026575387175) , 127-612/26 (04026575387311) , 127-612/35 (04026575387458) , 127-614/17 (04026575387182) , 127-614/26 (04026575387328) , 127-614/35 (04026575387465) , 127-616/17 (04026575387199) , 127-616/26 (04026575387335), 127-616/35 (04026575387472) , 127-618/17 (04026575387205) , 127-618/26 (04026575387342) , 127-618/35 (04026575387489) , 127-620/17 (04026575387212) , 127-620/26 (04026575387359) , 127-620/35 (04026575387496) , 127-622/17 (04026575387229) , 127-622/26 (04026575387366) , 127-622/35 (04026575387502) , 127-624/17 (04026575387236) , 127-624/26 (04026575387373) , 127-624/35 (04026575387519) , 127-626/17 (04026575387243) , 127-626/26 (04026575387380) , 127-626/35 (04026575387526) , 127-628/17 (04026575387250) , 127-628/26 (04026575387397) , 127-628/35 (04026575387533) , 127-630/17 (04026575387267) , 127-630/26 (04026575387403) , 127-630/35 (0402657 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1296-2024%22
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