Segmental Stem recall
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…
Why was Segmental Stem recalled?
Potential for breach of Tyvek seals.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Model Number: FS-11120-03M; UDI-DI: B278FS1112003M0; Lot Numbers: 1880532, 1880533, 1880534, 1880535, 1880536, 1880537, 1880538, 1880539, 1880540, 1880541, 1880542, 1880543. b. Model Number: FS-12120-03M; UDI-DI: B278FS1212003M0; Lot Numbers: 1880544, 1880545, 1880546, 1880547, 1880548, 1880549, 1880550, 1880551, 1880552, 1880553. c. Model Number: FS-13120-03M; UDI-DI: B278FS1312003M0; Lot Numbers: 1880554, 1880555, 1880556, 1880557, 1880558, 1880559, 1880560, 1880561, 1880562, 1880563. d. Model Number: FS-14120-03M; UDI-DI: B278FS1412003M0; Lot Numbers: 1880564, 1880565, 1880566, 1880567, 1880568, 1880569, 1880570, 1880571, 1880572, 1880573, 1880574. e. Model Number: FS-15120-03M; UDI-DI: B278FS1512003M0; Lot Numbers: 1880575, 1880576, 1880577, 1880578, 1880579, 1880580, 1880581, 1880582, 1880583, 1880584, 1880585, 1880586, 1880587. f. Model Number: FS-16120-03M; UDI-DI: B278FS1612003M0; Lot Numbers: 1880588, 1880589, 1880590, 1880591, 1880592, 1880593, 1880594, 1880595, 1880596, 1880597, 1880598. g. Model Number: FS-17120-03M; UDI-DI: B278FS1712003M0; Lot Numbers: 1880599, 1880600, 1880601, 1880602, 1880603, 1880604, 1880605, 1880606, 1880607, 1880608, 1880609, 1880610, 1880611. h. Model Number: FS-18120-03M; UDI-DI: B278FS1812003M0; Lot Numbers: 1880612, 1880613, 1880614, 1880615, 1880616, 1880617, 1880618, 1880619, 1880620, 1880621, 1880622, 1880623. i. Model Number: FS-19120-03M; UDI-DI: B278FS1912003M0; Lot Numbers: 1880624, 1880625, 1880626, 1880627, 1880628, 1880629, 1880630, 1880631, 1880632. j. Model Number: FS-20120-03M; UDI-DI: B278FS2012003M0; Lot Numbers: 1880633, 1880634, 1880635, 1880636, 1880637, 1880638, 1880639. k. Model Number: FS-21120-03M; UDI-DI: B278FS2112003M0; Lot Numbers: 1880640, 1880641, 1880642, 1880643, 1880644, 1880645, 1880646, 1880647, 1880648, 1880649, 1880650, 1880651.
- Product
- 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…
- Recalling firm
- Onkos Surgical, Inc.
- Quantity
- 120 units
- 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.
- Recall date
- June 4, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)