Food, drugs, devices › Smith & Nephew, Inc.
Device recall: smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, Q
Smith & Nephew, Inc. (Memphis, TN) initiated this device recall on 24 Jul 2017; FDA lists 1 product record under event 77827, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 21 Aug 2020. Initiation: voluntary: firm initiated. Smith & Nephew, Inc. has 107 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Smith & Nephew, Inc., Memphis, TN.
Reason for recall
"The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures."
Distribution
"Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 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… | 402 units | Class II | Terminated | 6 Sep 2017 |
Context
Other enforcement events for Smith & Nephew, Inc.
All 107 events for Smith & Nephew, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.