Recall Z-1881-2025
Onkos Surgical, Inc. · initiated September 1, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Codes / lots: 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…
Reason for recall
Potential for breach of Tyvek seals.
FDA-determined cause: Packaging change control
Action taken
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.
Details
- Recall number
- Z-1881-2025
- Initiated
- September 1, 2023
- Posted by FDA
- May 29, 2025
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- 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.
- Recalling firm
- Onkos Surgical, Inc., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1879-2025 Class II | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1880-2025 Class II | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1882-2025 Class II | Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1883-2025 Class II | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |
| Z-1884-2025 Class II | Male-Female Midsection with the following sizes and model numbers. a. Male-Female…Potential for breach of Tyvek seals. | 09/01/2023Open, Classified |