Class 2 Device Recall Modular REDAPT(TM) Hip Systems

• Date Initiated by Firm: November 15, 2016
• Create Date: January 04, 2017
• Recall Status: Terminated on August 19, 2019
• Recall Number: Z-0944-2017
• Recall Event ID: 75873
• 510(K)Number: K121627
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
• Product: Modular REDAPT(TM) Hip Systems 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 capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.
• Code Information: 71354001 MDF REV IMPLANT 240MM SZ 11 71354002 MDF REV IMPLANT 240MM SZ 13 71354003 MDF REV IMPLANT 240MM SZ 14 71354004 MDF REV IMPLANT 240MM SZ 15 71354005 MDF REV IMPLANT 240MM SZ 16 71354006 MDF REV IMPLANT 240MM SZ 17 71354007 MDF REV IMPLANT 240MM SZ 18 71354008 MDF REV IMPLANT 240MM SZ 19 71354009 MDF REV IMPLANT 240MM SZ 20 71354011 MDF REV IMPLANT 240MM SZ 21 71354012 MDF REV IMPLANT 240MM SZ 23 71354013 MDF REV IMPLANT 240MM SZ 25 71354015 MDF REV IMPLANT 300MM SZ 11 71354016 MDF REV IMPLANT 300MM SZ 13 71354017 MDF REV IMPLANT 300MM SZ 14 71354018 MDF REV IMPLANT 300MM SZ 15 71354019 MDF REV IMPLANT 300MM SZ 16 71354021 MDF REV IMPLANT 300MM SZ 17 71354022 MDF REV IMPLANT 300MM SZ 18 71354023 MDF REV IMPLANT 300MM SZ 19 71354024 MDF REV IMPLANT 300MM SZ 20 71354025 MDF REV IMPLANT 300MM SZ 21 71354026 MDF REV IMPLANT 300MM SZ 23 71354027 MDF REV IMPLANT 300MM SZ 25 71354312 REDAPT PF STEM 240MM SZ 12 71354313 REDAPT PROXIMALLY FLUTED STEM 240MM SZ 13 71354314 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 14 71354315 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 15 71354316 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 16 71354317 REDAPT PROXIMALLY FLUTED {} STEM 240MM SZ 17 71354318 REDAPT PROXIMALLY FLUTED STEM-240MM SZ 18 71354319 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 19 71354320 REDAPTPROXIMALLY FLUTED STEM- 240MM SZ 20 71354321 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 21 71354322 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 22 71354323 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 23 71354324 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 24 71354325 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 25 71354326 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 26 71354327 REDAPT PROXIMALLY FLUTED STEM- 240MM SZ 27 71354328 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 12 71354329 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 13 71354330 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 14 71354331 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 15 71354332 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 16 71354333 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 17 71354334 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 18 71354335 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 19 71354336 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 20 71354337 REDAPT PROXIMALLY FLUTED STEM- 300MM SZ 21 71354338 REDAPT PF STEM-300MM SZ 22 71354339 REDAPT PF STEM-300MM SZ 23 71354340 REDAPT PF STEM-300MM SZ 24 71354341 REDAPT PF STEM 300MM SZ 25 71354360 REDAPT MODULAR SLVD STEM 240MM SZ 15 71354361 REDAPT MODULAR SLVD STEM 240MM SZ 16 71354362 REDAPT MODULAR SLVD STEM 240MM SZ 17 71354363 REDAPT MODULAR SLVD STEM 240MM SZ 18 71354364 REDAPT MODULAR SLVD STEM 240MM SZ 19 71354365 REDAPT MODULAR SLVD STEM 240MM SZ 20 71354366 REDAPT MOD SLVD STEM 240MM SZ 21 71354367 REDAPT MOD SLVD STEM 240MM SZ 22 71354368 REDAPT MOD SLVD STEM 240MM SZ 23 71354369 REDAPT MOD SLVD STEM 240MM SZ 24 71354370 REDAPT MOD SLVD STEM 240MM SZ 25 71354371 REDAPT MOD SLVD STEM 240MM SZ 26 71354372 REDAPT MOD SLVD STEM 240MM SZ 27 71354374 REDAPT MOD SLVD STEM 300MM SZ 12 71354375 REDAPT MOD SLVD STEM 300MM SZ 13 71354376 REDAPT MOD SLVD STEM 300MM SZ 14 71354377 REDAPT MOD SLVD STEM 300MM SZ 15 71354378 REDAPT MOD SLVD STEM 300MM SZ 16 71354379 REDAPT MOD SLVD STEM 300MM SZ 17 71354380 REDAPT MOD SLVD STEM 300MM SZ 18 71354381 REDAPT MOD SLVD STEM 300MM SZ 19 71354382 REDAPT MOD SLVD STEM 300MM SZ 20 71354383 REDAPT MOD SLVD STEM 300MM SZ 21 71354384 REDAPT MOD SLVD STEM 300MM SZ 22 71354385 REDAPT MOD SLVD STEM 300MM SZ 23 71354386 REDAPT MOD SLVD STEM 300MM SZ 24 71354387 REDAPT MOD SLVD STEM 300MM SZ 25 71354388 REDAPT MOD SLVD STEM 300MM SZ 26 71354389 REDAPT MOD SLVD STEM 300MM SZ 27 71354404 REDAPT PF STEM 300MM SZ 26 71354405 REDAPT PF STEM 300MM SZ 27 71354407 REDAPT MOD SLEEVED STEM 240MM SZ 12 71354408 REDAPT MOD SLVD STEM 240MM SZ 13 71354409 REDAPT MODULAR SLVD STEM 240MM SZ 14 71354002 MDF REV IMPLANT 240MM SZ 13 71354003 MDF REV IMPLANT 240MM SZ 14 71354004 MDF REV IMPLANT 240MM SZ 15 71354005 MDF REV IMPLANT 240MM SZ 16 71354006 MDF REV IMPLANT 240MM SZ 17 71354007 MDF REV IMPLANT 240MM SZ 18 71354008 MDF REV IMPLANT 240MM SZ 19 71354009 MDF REV IMPLANT 240MM SZ 20 71354011 MDF REV IMPLANT 240MM SZ 21 71354012 MDF REV IMPLANT 240MM SZ 23 71354013 MDF REV IMPLANT 240MM SZ 25 71354016 MDF REV IMPLANT 300MM SZ 13 71354017 MDF REV IMPLANT 300MM SZ 14 71354018 MDF REV IMPLANT 300MM SZ 15 71354019 MDF REV IMPLANT 300MM SZ 16 71354021 MDF REV IMPLANT 300MM SZ 17 71354022 MDF REV IMPLANT 300MM SZ 18 71354023 MDF REV IMPLANT 300MM SZ 19 71354024 MDF REV IMPLANT 300MM SZ 20 71354025 MDF REV IMPLANT 300MM SZ 21 71354026 MDF REV IMPLANT 300MM SZ 23 71354027 MDF REV IMPLANT 300MM SZ 25
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: David Snyder; 978-749-1440
• Manufacturer Reason for Recall: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
• FDA Determined 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 in Commerce: 6266 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MEH