smith&nephew POLARSTEM — Class II medical device recall Z-3100-2017
Terminated recall by Smith & Nephew, Inc., reported 2017-09-06, distributed nationwide. The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple proced
| Recall number | Z-3100-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2017-07-24 |
| Classified | 2017-08-29 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, NO |
| Quantity | 402 units |
| Reason classes | device malfunction |
| Lot numbers | A57835, A57837, A58509, A59084, A59446, A59547, A60948 |
| Model numbers | 76102260 |
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 for recall
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3100-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.