FDA Device recall Z-1880-2025
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS L…
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS L… by Onkos Surgical, citing potential for breach of Tyvek seals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1880-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-01 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Onkos Surgical |
| Distribution | AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NC, NE, NJ, OH, PA, TX, WA, WI |
Product
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Reason
Potential for breach of Tyvek seals.
Identifiers
| code_info | a. Model Number: CB-11152-03M; UDI-DI: B278CB1115203M0; Lot Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 18802…a. Model Number: CB-11152-03M; UDI-DI: B278CB1115203M0; Lot Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268, 1880269, 1880270, 1880271, 1880272, 1880273, 1880274. b. Model Number: CB-13152-03M; UDI-DI: B278CB1315203M0; Lot Numbers: 1880275, 1880276, 1880277, 1880278, 1880279, 1880280, 1880281, 1880282, 1880283, 1880284. c. Model Number: CB-15152-03M; UDI-DI: B278CB1515203M0; Lot Numbers: 1880285, 1880286, 1880287, 1880288, 1880289, 1880290, 1880291, 1880292, 1880293, 1880294, 1880295, 1880296. d. Model Number: CB-17152-03M; UDI-DI: B278CB1715203M0; Lot Numbers: 1880297, 1880298, 1880299, 1880300, 1880301, 1880302, 1880303, 1880304, 1880305, 1880306, 1880307. |
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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-1880-2025%22
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