Recall Z-3100-2017 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Smith & Nephew, Inc.
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 75102260, 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
| Date | Aug 29, 2017 (initiated Jul 24, 2017) |
| Status | Terminated |
| Reason | The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. |
| 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 FieldActions@smith-nephew.com. For questions regarding this recall ca |
| Quantity | 402 units |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA Smith & Nephew, Inc., Oct 10, 2013 |