510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 803 of 1190
FDA device recalls, page 803 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1269-2012Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a...Leica Microsystems, Inc.FSO
Z-1203-2012Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler...Mizuho Orthopedic Systems IncFWZ
Z-1652-2013Class IILithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920...Braemar Manufacturing, LLCDRG
Z-2159-2012Class IIICobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas...Roche Molecular Systems IncOOI
Z-2078-2012Class IISiemens syngo.plaza. Radiological image processing systemSiemens Medical Solutions USA, Inc.LLZ
Z-1611-201200-5976-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1610-201200-5972-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1609-201200-5970-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1608-201200-5976-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1607-201200-5976-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1606-201200-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1605-201200-5976-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1604-201200-5976-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1603-2012REF 00-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1602-201290-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1601-2012REF 90-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1600-2012REF 90-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1599-2012REF 90-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1598-2012REF 90-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1597-2012REF 90-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1596-2012REF 00-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1595-2012REF 00-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1594-2012REF 00-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1593-2012REF 00-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1592-2012REF 00-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1591-2012REF 00-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1590-2012REF 90-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1589-2012REF 90-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1588-2012REF 00-5972-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1587-2012REF 00-5972-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1586-2012REF 00-5972-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1585-2012REF 00-5972-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1584-2012REF 00-5972-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1583-2012REF 00-5952-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1582-2012REF 00-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1581-2012REF 00-5952-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1580-201200-5952-31-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1579-201200-5952-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene...Zimmer GmbHJWH
Z-1578-201200-5976-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1577-201200-5976-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1576-201200-5976-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1575-201200-5976-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1574-201200-5972-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1573-201200-5972-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1572-201200-5972-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1571-201200-5972-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1570-201200-5972-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1569-201200-5972-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1568-201290-5970-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1567-201290-5970-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH