Reported Oct 13, 2021 · Ongoing
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts;…
Exactech, 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: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- TRULIANT Knee System including TRULIANT Tibial Inserts
- also labeled as the followinga. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts
- NOTEInformation reflects Exactech recall expansion initiated on 02/07/2022
- Lot codes and dates
- a. Item Number (Device Identifier
- Serial number(s))
2,786 of 2,786 codes
02-022-47-1009 (10885862306067490435849043624904363490436551030125132420513243251861195186125518612852204275220428)02-022-47-1010 (1088586230607450542655054269505427250583955058402506332850633305063335506333651438085143812)02-022-47-1011 (10885862306081471551448491215101155510116451083025108315)02-022-47-1012 (10885862306098505959850595995059601507333050733345073349507335250733595073378)02-022-47-1013 (108858623061044758320475832649043794904391510141351533015153309515331751745435174555)02-022-47-1015 (10885862306128490431349043174904331510333051249295217018)
- Serial number(s))
452 of 452 codes
02-022-48-1009 (1088586230670847238554907359506358150635895227118)02-022-48-1011 (1088586230671547727344848972484897552337105233712)02-022-48-1013 (108858623067224696463490734849073495261083)02-022-48-1509 (1088586230673950093785009386500939850093995018667501867150186765227203)02-022-48-1511 (1088586230674650360655036074503608050360965254509)02-022-48-1513 (1088586230675350585435058551505855650585675058574510667252610975261102)02-022-48-2009 (10885862306760475327347532754753278477335247733544773355477335749206304920632492063349206344920635492063851032515103259510326051324925132494
- Serial number(s))
91 of 91 codes
02-022-49-1009 (1088586230703347898145226542)02-022-49-1509 (10885862307064503646750364735036482503648350637675063771508557851201585249382)02-022-49-1511 (10885862307071503724850971155097133)02-022-49-2009 (1088586230709547576264757630475763147576324850863492157549215774921583510328051032855132660513266352217115221730522173852217405384798)02-022-49-2011 (1088586230710146737664758315521734352173485217352)02-022-49-2013 (10885862307118475765350969705220745)02-022-49-2509 (1088586230712546738974673899467390246739044673905467390647642294764231476423649083744908382490838549215014921502
- Amount recalled
- 31,201 devices
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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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