FDA Device recall Z-3100-2017
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only Th…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only Th… by Smith And Nephew, citing the Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3100-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-24 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
Reason
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Identifiers
| code_info | Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3100-2017%22
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