smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA recall
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject…
Why was smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA recalled?
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
- 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…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 402 units
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
- Recall date
- September 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)