Reported Jun 19, 2019 · Terminated
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Conformis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Conformis, Inc. · 600 Technology Park Dr · Billerica, MA · 01821-4154
Is this the product you have?
- Conformis iTotal Hip Replacement SystemHBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
- Lot codes and dates
- HBS-033-0010-010101Serial
- Numbers
423398424244424392425455425607425755426309427186428901430404430766431394431844434871436520438363438925439064439561440369441662441734
- HBS-033-0011-010101Serial
- Numbers
422796424450424510426034426118430150430534431142431502431581432030433555434136434439435282436108436212437452437657437745437968440603442816
- HBS-033-0012-010101Serial
- Numbers
425346425608425866427702427754429459429844430053430087432011432363436792437653438516439063440253
- HBS-033-0013-010101Serial
- Numbers
422797424647425456426297427360427898428372428957429014429921429937430338430613430962433445434149434451434635435118436125436230436333437073438024438112439641439929441028441030
- HBS-033-0014-010101Serial
- Numbers
423231425276426069426382427480427752427883428820428900431315431333431977432543432953434612435649435883435910436122437322437863438631440445
- HBS-033-0015-010101Serial
- Numbers
429552432936433085437373437681437925439272 HBS-033-0016-010101 425418428545431199435657436790437425437656442745
- HBS-033-0016-010101Serial
- Numbers
425418428545431199435657436790437425437656442745
- Amount recalled
- 128
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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