Recall Z-0945-2017 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Smith & Nephew, Inc.
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped cap
| Date | Nov 15, 2016 |
| Status | Terminated |
| Reason | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. |
| Root cause | Device Design |
| Action | Smith & Nephew sent an Urgent Product Recall Notification letter dated November 15, 2016, to all affected customers. Customers were instructed to inspect their inventory and locate any unused devices and quarantine immediately. Complete the Inventory Return Certification Form and obtain a return authorization (RA) number if there was product to return. For questions regarding this recall call 978-749-1440. |
| 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 |
| FDA record | Open on fda.gov |