CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report
Polarstem(TM) Femoral Stems with Ti/HA (Standard, Lateral recalled
Smith & Nephew is recalling Polarstem(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), distributed nationwide in the US. The recall was initiated on 24 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3100-2017
- FDA event ID
- 77827
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2017
- FDA classified
- 29 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 24 Jul 2017 | Recall initiated by company | |
| 29 Aug 2017 | Classified by FDA | +36 days |
| 6 Sep 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Questions about this recall
Why was it recalled?
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Which lots are affected?
Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
Where was it sold?
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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