Smith & Nephew Recalls Polarstem Cardan Joints Due to Fracture Risk
Smith & Nephew is recalling 402 Polarstem Cardan joints because the device may fracture or fail after multiple uses.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device fracture) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 402 units of the Polarstem Cardan joint, a medical instrument used to implant POLARSTEM femoral stems. The recall affects specific lot numbers: A57835, A57837, A58509, A59084, A59446, A59547, and A60948. The devices were distributed nationwide in the United States and internationally to Australia, Belgium, Norway, and Switzerland.
The recall was initiated because the Cardan joint could potentially fracture or functionally fail after multiple procedures. The instrument is used in conjunction with a curved stem impactor to mount and impact the hip stem into the femur. No specific dates or additional distribution details are provided in the source text.
Healthcare providers and consumers should stop using the affected Cardan joints immediately. Smith & Nephew, Inc. is the recalling firm and should be contacted for further instructions on how to return or dispose of the devices.
The recalled product
- 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 s
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 402
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: A57835
- A57837
- A58509
- A59084
- A59446
- A59547
- A60948
Distribution
Distributed nationwide across the United States.
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