Reported Jun 19, 2019 · Terminated
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
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-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
- Lot codes and dates
- HBS-033-0010-020101Serial
- Numbers
425365425428425767425954426249426408426508426722426725428146428328429186429310429857430590431869432271432292432555432773433524434063436063436522438792439464439559441029
- HBS-033-0011-020101Serial
- Numbers
423937424879425273425425425457425605425627426730427699427760427897428066428791428802429699429829429856429940430691431029432687434510435069435409435886435961436017436659437864437866438568439309439457439650441929
- HBS-033-0012-020101Serial
- Numbers
424288424377426081426298426581426608426873427353427759428504428744428814428940429787429854429928430045430344430780431025431032431443431813432098432925434265434704435120435483435790436682436891437036437050438471438511438570439453439471439738441009441527442347
- HBS-033-0013-020101Serial
- Numbers
423539425277426121430033430129430461432012434291435938436951437614437654437776437932438157438304438384439822440273440446441053441714442149
- HBS-033-0014-020101Serial
- Numbers
423852425345425968426897427830428294428697428836429416430028431541432156432399432421432440432524433245434239434884435146435366437208438079438485438916438991439849440604440673441492
- HBS-033-0015-020101Serial
- Numbers
426179429192429828429855431489431512432017433642436330437089437495437651437714437906438105438296438739438784440265
- HBS-033-0016-020101Serial
- Numbers
426119435562437516438708440704
- Amount recalled
- 183
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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