FDA Device recall Z-1381-2018
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving comple…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving comple… by Zimmer Biomet, citing there is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1381-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-29 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Reason
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Identifiers
| code_info | 11002427 11004885 11005449 11006334 11006335 11008928 61369868 61369869 61399454 61399456 61402368 61427788…11002427 11004885 11005449 11006334 11006335 11008928 61369868 61369869 61399454 61399456 61402368 61427788 61427789 61427790 61532231 61532232 61532233 61532234 61532235 61532236 61532237 61532238 61532239 61532241 61551139 61551140 61551141 61636762 61646779 61651745 61673447 61711591 61718216 61730528 61736057 61754485 61765397 61771371 61774299 61853520 61858613 61863256 61863257 61872494 61872495 61877127 61881912 61881913 61886497 61890895 61890896 61890897 61896238 61906572 61932477 61938143 61948661 61948662 61948663 61948664 61948665 61948666 61948667 61948668 61987706 61987707 61993688 61993689 62001043 62001044 62001045 62006906 62006907 62025413 62025414 62025415 62025416 62025417 62032847 62038122 62038123 62050139 62064439 62064441 62068642 62068643 62095951 62118361 62145857 62145858 62145859 62145860 62182529 62182530 62182532 62194346 62194347 62207101 62207102 62207103 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1381-2018%22
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