Segmental Stem Canal Filling 152MM (Onkos Surgical) – Tyvek seal breach (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Brand
Onkos Surgical, Inc.
Lot Codes / Batch Numbers
a. Model Number: FB-11152-03M, UDI-DI: B278FB1115203M0, Lot Numbers: 1880455, 1880456, 1880457, 1880458, 1880459, 1880460, 1880461, 1880462, 1880463. b. Model Number: FB-12152-03M, UDI-DI: B278FB1215203M0, Lot Numbers: 1880464, 1880465, 1880466, 1880467, 1880468, 1880469. c. Model Number: FB-13152-03M, UDI-DI: B278FB1315203M0, Lot Numbers: 1880470, 1880471, 1880472, 1880473. d. Model Number: FB-14152-03M, UDI-DI: B278FB1415203M0, Lot Numbers: 1880474, 1880475, 1880476. e. Model Number: FB-15152-03M, UDI-DI: B278FB1515203M0, Lot Numbers: 1880477, 1880478, 1880479. f. Model Number: FB-16152-03M, UDI-DI: B278FB1615203M0, Lot Numbers: 1880480, 1880481, 1880482, 1880483, 1880484, 1880485, 1880486, 1880487, 1880488. g. Model Number: FB-17152-03M, UDI-DI: B278FB1715203M0, Lot Numbers: 1880489, 1880490, 1880491, 1880492, 1880493, 1880494, 1880495, 1880496, 1880497. h. Model Number: FB-18152-03M, UDI-DI: B278FB1815203M0, Lot Numbers: 1880498, 1880499, 1880500, 1880501, 1880502, 1880503, 1880504, 1880505. i. Model Number: FB-19152-03M, UDI-DI: B278FB1915203M0, Lot Numbers: 1880506, 1880507, 1880508, 1880509, 1880510, 1880511. j. Model Number: FB-20152-03M, UDI-DI: B278FB2015203M0, Lot Numbers: 1880512, 1880513, 1880514, 1880515, 1880516, 1880517, 1880518. k. Model Number: FB-21152-03M, UDI-DI: B278FB2115203M0, Lot Numbers: 1880519, 1880520, 1880521, 1880522, 1880523, 1880524, 1880525, 1880526, 1880527, 1880528, 1880529, 1880530, 1880531.
Products Sold
a. Model Number: FB-11152-03M; UDI-DI: B278FB1115203M0; Lot Numbers: 1880455, 1880456, 1880457, 1880458, 1880459, 1880460, 1880461, 1880462, 1880463. b. Model Number: FB-12152-03M; UDI-DI: B278FB1215203M0; Lot Numbers: 1880464, 1880465, 1880466, 1880467, 1880468, 1880469. c. Model Number: FB-13152-03M; UDI-DI: B278FB1315203M0; Lot Numbers: 1880470, 1880471, 1880472, 1880473. d. Model Number: FB-14152-03M; UDI-DI: B278FB1415203M0; Lot Numbers: 1880474, 1880475, 1880476. e. Model Number: FB-15152-03M; UDI-DI: B278FB1515203M0; Lot Numbers: 1880477, 1880478, 1880479. f. Model Number: FB-16152-03M; UDI-DI: B278FB1615203M0; Lot Numbers: 1880480, 1880481, 1880482, 1880483, 1880484, 1880485, 1880486, 1880487, 1880488. g. Model Number: FB-17152-03M; UDI-DI: B278FB1715203M0; Lot Numbers: 1880489, 1880490, 1880491, 1880492, 1880493, 1880494, 1880495, 1880496, 1880497. h. Model Number: FB-18152-03M; UDI-DI: B278FB1815203M0; Lot Numbers: 1880498, 1880499, 1880500, 1880501, 1880502, 1880503, 1880504, 1880505. i. Model Number: FB-19152-03M; UDI-DI: B278FB1915203M0; Lot Numbers: 1880506, 1880507, 1880508, 1880509, 1880510, 1880511. j. Model Number: FB-20152-03M; UDI-DI: B278FB2015203M0; Lot Numbers: 1880512, 1880513, 1880514, 1880515, 1880516, 1880517, 1880518. k. Model Number: FB-21152-03M; UDI-DI: B278FB2115203M0; Lot Numbers: 1880519, 1880520, 1880521, 1880522, 1880523, 1880524, 1880525, 1880526, 1880527, 1880528, 1880529, 1880530, 1880531.
Onkos Surgical, Inc. is recalling Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13 due to Potential for breach of Tyvek seals.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for breach of Tyvek seals.
Recommended Action
Per FDA guidance
Onkos Surgical began notifying consignees on about 09/01/2023 via email. Consignees were instructed to complete and return the response form providing the affected lot numbers being returned, coordinate the return of affected units, and to note that when placing these parts into totes, always place them flat.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, GA, HI, IL, IN, KS, KY, LA, MD, MS, NE, NJ, NC, OH, PA, TX, WA, WI
Page updated: Jan 10, 2026