US Endodontics, LLC: Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP14525

Hazard

Due to devices being irradiated above the established specification which my result in package integrity issues.

Details from the source

Reason for recall: Due to devices being irradiated above the established specification which my result in package integrity issues. Distribution: Worldwide - US Nationwide distribution in the state of GA and the countries of Australia, Canada, the European Union (specifically France, Germany, Italy, Poland, and Spain), and the UK. Quantity: Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)) Lot/code info: Device SKU / GTIN code AP120213PK / 00887919811343 Lot Numbers: 020222033 042624005 060320018 060420001 070820001 071321009 071321010 080523075 111819267 AP120253PK / 00887919811374 Lot Numbers: 042821235 042821235 042821236 042821236 042821238 051024026 051423101 051423102 060420003 060420004 063020331 063020332 063020333 080321003 080321004 080523077 080523078 101821059 101821060 101821061 101821062 101821063 120219105 121120218 121120221 121120222 121120223 AP120313PK / 00887919811404 Lot Number: 110821062 AP125213PK / 00887919811435 Lot Numbers: 021920313 030222002 030320002 041423016 072320011 101821056 101821057 101821058 111220210 111220211 111220212 111220213 111220214 121119001 AP125253PK / 00887919811466 Lot Numbers: 010622001 012121085 012121086 012121087 012121088 012121089 012121090 012121091 012121092 021920315 031620090 031620091 031620092 041224032 041224033 051221001 051221600 051423103 051423104 061620001 061620002 062323152 062323153 062921149 062921150 072721067 072721068 080523079 080523080 080523081 090220016 090220018 090220019 101821064 101821066 101821069 121521017 121521018 121521019 AP125313PK / 00887919811497 Lot Numbers: 030221289 050324127 061620004 080420319 AP135213PK / 00887919811527 Lot Numbers: 030221290 080523076 110821061 121521020 AP135253PK / 00887919811558 Lot Numbers: 040522008 040522009 081723036 081723037 120619106 061120031 072320012 080520055 AP135313PK / 00887919811589 Lot Number: 032322001 AP145213PK / 00887919811619 Lot Numbers:

UPC codes

00887919811343, 00887919811374, 00887919811404, 00887919811435, 00887919811466, 00887919811497, 00887919811527, 00887919811558, 00887919811589, 00887919811619, 00887919811640, 00887919811671, 00887919811701, 00887919811732, 00887919811763, 00810047641995, 00810047642008, 00810047642015, 00810047642022, 00810047642039, 00810047642046, 00810047641544, 00810047641551, 00810047641568, 00810047641575, 00810047641582, 00810047641599, 00810047641605, 00810047641612, 00810047641629, 00810047641636, 00810047641643, 00810047641650, 00810047641667, 00810047641674, 00810047641681, 00810047641698, 00810047641704, 00810047641711, 00810047641728

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.