Modular SMF(TM) The Modular SMF(TM) and Modular recall
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where…
Why was Modular SMF(TM) The Modular SMF(TM) and Modular recalled?
All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
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?
71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4 71352405 SMF STEM RSA SIZE 5 71352406 SMF STEM RSA SIZE 6 71352407 SMF STEM RSA SIZE 7 71352408 SMF STEM RSA SIZE 8 71352409 SMF STEM RSA SIZE 9 71352501 SMF STEM WITH STIKTITE SZ 1 71352502 SMF STEM WITH STIKTITE SZ 2 71352503 SMF STEM WITH STIKTITE SZ 3 71352504 SMF STEM WITH STIKTITE SZ 4 71352505 SMF STEM WITH STIKTITE SZ 5 71352506 SMF STEM WITH STIKTITE SZ 6 71352507 SMF STEM WITH STIKTITE SZ 7 71352508 SMF STEM WITH STIKTITE SZ 8 71352509 SMF STEM WITH STIKTITE SZ 9
- Product
- Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 11999 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Canada, Switzerland, China, Cyprus, Czech Republic, Dubai, Germany, Denmark, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Mexico, Netherlands, Poland, Puerto Rico, Portugal, Russia, Turkey, and South Africa.
- Recall date
- January 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)