FDA Medical devices recall ·
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH… recall
- Recall number
- Z-1880-2025
- Date
- (initiated September 1, 2023)
- Company / brand
- Onkos Surgical, Inc.
77 E Halsey Rd, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 49 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Potential for breach of Tyvek seals.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.
States: Arizona Florida Georgia Hawaii Illinois Kansas Kentucky Louisiana Maryland Mississippi North Carolina Nebraska New Jersey Ohio Pennsylvania Texas Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1880-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.