510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,528 records, page 749 of 1191
FDA device recalls, page 749 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1698-2013Class IIREF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1697-2013Class IIREF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1696-2013Class IIREF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1691-2013Class IMedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of...Cerenovus, Inc.LKK
Z-1695-2013Class IIREF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE...Zimmer GmbHHRY
Z-2044-2013Class II00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx...Zimmer GmbHJWH
Z-2043-2013Class II00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx...Zimmer GmbHJWH
Z-2042-2013Class II00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx...Zimmer GmbHJWH
Z-2041-2013Class II00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx...Zimmer GmbHJWH
Z-2040-2013Class II00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx...Zimmer GmbHJWH
Z-2039-2013Class II00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx...Zimmer GmbHJWH
Z-2038-2013Class II00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx...Zimmer GmbHJWH
Z-2037-2013Class II00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx...Zimmer GmbHJWH
Z-2036-2013Class II00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx...Zimmer GmbHJWH
Z-2035-2013Class II00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional...Zimmer GmbHJWH
Z-2034-2013Class II00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional...Zimmer GmbHJWH
Z-2033-2013Class II00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx...Zimmer GmbHJWH
Z-2032-2013Class II00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx...Zimmer GmbHJWH
Z-2031-2013Class II90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx...Zimmer GmbHJWH
Z-2030-2013Class II00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx...Zimmer GmbHJWH
Z-2029-2013Class II90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx...Zimmer GmbHJWH
Z-2028-2013Class II00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx...Zimmer GmbHJWH
Z-2027-2013Class II00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx...Zimmer GmbHJWH
Z-2026-2013Class II00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx...Zimmer GmbHJWH
Z-2025-2013Class II90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx...Zimmer GmbHJWH
Z-2024-2013Class II00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx...Zimmer GmbHJWH
Z-2023-2013Class II90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx...Zimmer GmbHJWH
Z-2022-2013Class II00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx...Zimmer GmbHJWH
Z-2021-2013Class II00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular...Zimmer GmbHJWH
Z-2020-2013Class II00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx...Zimmer GmbHJWH
Z-2019-2013Class II90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx...Zimmer GmbHJWH
Z-2018-2013Class II00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx...Zimmer GmbHJWH
Z-2017-2013Class II90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx...Zimmer GmbHJWH
Z-2016-2013Class II00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx...Zimmer GmbHJWH
Z-2015-2013Class II00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL...Zimmer GmbHJWH
Z-2014-2013Class II00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO...Zimmer GmbHJWH
Z-2013-2013Class II65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR...Zimmer GmbHJWH
Z-2012-2013Class II00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR...Zimmer GmbHJWH
Z-1607-2013Class IIMedtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra...Medtronic, Inc.NKE
Z-1668-2013Class IMedtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended...Medtronic, Inc.FPA
Z-1690-2013Class IMedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of...Cerenovus, Inc.LKK
Z-2011-2013Class II00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP...Zimmer GmbHJWH
Z-2010-2013Class II00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC...Zimmer GmbHJWH
Z-2009-2013Class II00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM...Zimmer GmbHJWH
Z-2008-2013Class II65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile...Zimmer GmbHJWH
Z-2007-2013Class II00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM...Zimmer GmbHJWH
Z-2006-2013Class II00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur...Zimmer GmbHJWH
Z-2005-2013Class II00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM...Zimmer GmbHJWH
Z-2004-2013Class II00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA...Zimmer GmbHJWH
Z-2003-2013Class II65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM...Zimmer GmbHJWH