Onkos Surgical, Inc. recalls Segmental Stem
Reason for recall
Potential for breach of Tyvek seals.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Lot / code information
- Model
- FS-11120-03M
- UDI
- B278FS1112003M0
- Lot #
- 1880532, 1880533, 1880534, 1880535, 1880536, 1880537, 1880538, 1880539, 1880540, 1880541, 1880542, 1880543. b
- Model
- FS-12120-03M
- UDI
- B278FS1212003M0
- Lot #
- 1880544, 1880545, 1880546, 1880547, 1880548, 1880549, 1880550, 1880551, 1880552, 1880553. c
- Model
- FS-13120-03M
- UDI
- B278FS1312003M0
- Lot #
- 1880554, 1880555, 1880556, 1880557, 1880558, 1880559, 1880560, 1880561, 1880562, 1880563. d
- Model
- FS-14120-03M
- UDI
- B278FS1412003M0
- Lot #
- 1880564, 1880565, 1880566, 1880567, 1880568, 1880569, 1880570, 1880571, 1880572, 1880573, 1880574. e
- Model
- FS-15120-03M
- UDI
- B278FS1512003M0
- Lot #
- 1880575, 1880576, 1880577, 1880578, 1880579, 1880580, 1880581, 1880582, 1880583, 1880584, 1880585, 1880586, 1880587. f
- Model
- FS-16120-03M
- UDI
- B278FS1612003M0
- Lot #
- 1880588, 1880589, 1880590, 1880591, 1880592, 1880593, 1880594, 1880595, 1880596, 1880597, 1880598. g
- Model
- FS-17120-03M
- UDI
- B278FS1712003M0
- Lot #
- 1880599, 1880600, 1880601, 1880602, 1880603, 1880604, 1880605, 1880606, 1880607, 1880608, 1880609, 1880610, 1880611. h
- Model
- FS-18120-03M
- UDI
- B278FS1812003M0
- Lot #
- 1880612, 1880613, 1880614, 1880615, 1880616, 1880617, 1880618, 1880619, 1880620, 1880621, 1880622, 1880623. i
- Model
- FS-19120-03M
- UDI
- B278FS1912003M0
- Lot #
- 1880624, 1880625, 1880626, 1880627, 1880628, 1880629, 1880630, 1880631, 1880632. j
- Model
- FS-20120-03M
- UDI
- B278FS2012003M0
- Lot #
- 1880633, 1880634, 1880635, 1880636, 1880637, 1880638, 1880639. k
- Model
- FS-21120-03M
- UDI
- B278FS2112003M0
- Lot #
- 1880640, 1880641, 1880642, 1880643, 1880644, 1880645, 1880646, 1880647, 1880648, 1880649, 1880650, 1880651
Show 23 more code fieldsShow fewer
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1881-2025
- FDA 510(k) clearance · K161520The device's official FDA premarket clearance record
- FDA device classification · KROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3510The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Onkos Surgical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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