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U.S. Department of Health and Human Services

Class 2 Device Recall Conformis

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 Class 2 Device Recall Conformissee related information
Date Initiated by FirmMarch 29, 2019
Create DateJune 13, 2019
Recall Status1 Terminated 3 on April 28, 2020
Recall NumberZ-1775-2019
Recall Event ID 82722
510(K)NumberK162719 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductConformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Code Information 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  
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information ContactSAME
781-345-9001
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionConformis issued on 29 Mar 2019 via e-mails to surgeons with upcoming surgeries the following: 1. For surgeons who have already performed the surgeries (i.e. for patients whose implant surgeries were completed between July 31st, 2018 and March 27th, 2019), a letter sent letter advising them of the issue. Confirmation of receipt will be requested. 2. For surgeons who have not performed the surgeries, but have approved the iView surgical plan on or before March 27, 2019, and Conformis has been notified of confirmed surgery dates or Conformis has provided commitment dates on or before May 17th 2019, a. They will be provided with a marked-up iView surgical plan that provides the true dimensions of the manufactured implant and asked to choose to (i) continue with surgery, (ii) postpone surgery to allow Conformis to manufacture a new implant with a head/neck length matching the original approved iView or (iii) cancel the order. b. Should the physician choose to proceed with the surgery using the manufactured implant with the 3 mm discrepancy, it will be shipped to them after receiving their written approval provided that the surgery is scheduled on or before May 17, 2019. c. Should the physician choose to postpone surgery, a new implant will be manufactured to match the approved iView and provided to the surgeon
Quantity in Commerce128
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPH
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