[pending] Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-
Pending LLM rewrite. Source: FDA_DEVICE Z-1880-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for breach of Tyvek seals.
The recalled product
- 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
- Manufacturer
- Onkos Surgical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 18 states:
- AZ
- FL
- GA
- HI
- IL
- KS
- KY
- LA
- MD
- MS
- NC
- NE
- NJ
- OH
- PA
- TX
- WA
- WI
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