Conformis iTotal Hip Replacement System recall
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Why was Conformis iTotal Hip Replacement System recalled?
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
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?
HBS-033-0010-010101: Serial Numbers:423398, 424244, 424392, 425455, 425607, 425755, 426309, 427186, 428901, 430404,430766, 431394,431844, 434871, 436520, 438363, 438925, 439064, 439561, 440369, 441662, 441734; HBS-033-0011-010101: Serial Numbers:422796, 424450, 424510, 426034, 426118, 430150, 430534, 431142, 431502, 431581, 432030, 433555, 434136, 434439, 435282, 436108, 436212, 437452, 437657, 437745, 437968, 440603, 442816; HBS-033-0012-010101: Serial Numbers: 425346, 425608, 425866, 427702, 427754, 429459, 429844, 430053, 430087, 432011, 432363, 436792, 437653, 438516, 439063, 440253; HBS-033-0013-010101: Serial Numbers: 422797, 424647, 425456, 426297, 427360, 427898, 428372, 428957, 429014, 429921, 429937, 430338, 430613, 430962, 433445, 434149, 434451, 434635, 435118, 436125, 436230, 436333, 437073, 438024, 438112, 439641, 439929, 441028, 441030; HBS-033-0014-010101: Serial Numbers: 423231, 425276, 426069, 426382, 427480, 427752, 427883, 428820, 428900, 431315, 431333, 431977, 432543, 432953, 434612, 435649, 435883, 435910, 436122, 437322, 437863, 438631, 440445; HBS-033-0015-010101: Serial Numbers: 429552, 432936, 433085, 437373, 437681, 437925, 439272 HBS-033-0016-010101 425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745; HBS-033-0016-010101: Serial Numbers:425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745
- Product
- Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
- Recalling firm
- Conformis, Inc.
- Quantity
- 128
- Distribution
- Nationwide
- Recall date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)