Z-3100-2017Class II

smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON...

Name: Z-3100-2017 smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON...
Creator: Smith & Nephew, Inc.
Published: 2017-07-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-07-24 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2017-07-24. FDA classified it as Class II and gives the reason as "The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3100-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Posted: 2017-08-29
Terminated: 2020-08-21
Recalling firm: Smith & Nephew, Inc.
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
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Root cause tag: design
FDA root cause: Device Design
Action: Smith & Nephew sent an Urgent Medical Device Recall Notice dated July 24, 2017, to all affected consignees. The firm notified their consignees by email and Fed Ex on 07/24/2017. Consignees have been asked to inspect inventory to locate and quarantine affected product. All consignees were asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew. Customers with questions were instructed to contact [email protected]. For questions regarding this recall call 978-749-1440.
Quantity in commerce: 402 units
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Product codes and lots: Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3100-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3100-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29

Product code LZO

K130728Class IIPolarstem Standard and Lateral Femoral Stems with Ti/haSmith & Nephew, Inc. / cleared 2013-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)