510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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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 485 of 1191
FDA device recalls, page 485 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1054-2018Class IIZUK PRC FEM SZB RMED/LLAT ZUK PRC FEM SZC LMED/RLAT ZUK PRC FEM SZC RMED/LLAT NGU PRC FEM...Zimmer GmbHHSX
Z-1053-2018Class IIZIMMER PATELLA FEMORAL JOINT Osteoarthritis, traumatic arthritis, polyarthritis, and/or...Zimmer GmbHKRR
Z-1052-2018Class IIPATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL Osteoarthritis, traumatic...Zimmer GmbHKRR
Z-1051-2018Class IIPRCT MIS CR MOB PLT SZ 4 L PRCT MIS CR MOB PLT SZ 5 L PRCT MIS CR MOB PLT SZ 6 L PRCT MIS...Zimmer GmbHNJL
Z-1050-2018Class IICR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX...Zimmer GmbHJWH
Z-1049-2018Class IICR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT...Zimmer GmbHJWH
Z-1048-2018Class IICR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is...Zimmer GmbHMBH
Z-1047-2018Class IICR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX...Zimmer GmbHJWH
Z-1046-2018Class IICR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT...Zimmer GmbHJWH
Z-1045-2018Class IINEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with...Zimmer GmbHNJL
Z-1044-2018Class IILPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL...Zimmer GmbHNJL
Z-1043-2018Class IILPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL...Zimmer GmbHNJL
Z-1042-2018Class IICR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR...Zimmer GmbHJWH
Z-1041-2018Class IICR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR...Zimmer GmbHJWH
Z-1040-2018Class IILPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device...Zimmer GmbHNJL
Z-1039-2018Class IILPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ...Zimmer GmbHMBH
Z-1038-2018Class IILPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated...Zimmer GmbHNJL
Z-1037-2018Class IILCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT...Zimmer GmbHJWH
Z-1238-2018Class IIPersona Partial Knee spacer block instruments; (1) 8mm block, Model Number...Zimmer GmbHHSX
Z-0677-2018Class IIRapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200QHologic, Inc.LKV
Z-0676-2018Class IIRapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Hologic, Inc.LKV
Z-1036-2018Class IILPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM...Zimmer GmbHNJL
Z-1035-2018Class IILPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL...Zimmer GmbHNJL
Z-1034-2018Class IILPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and...Zimmer GmbHJWH
Z-1033-2018Class IINP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT...Zimmer GmbHJWH
Z-1032-2018Class IICR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR...Zimmer GmbHMBH
Z-1031-2018Class IICR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L...Zimmer GmbHMBH
Z-1030-2018Class IICR POR FEM HATCP SIZE E/L SIZE F/L Knee ProsthesisZimmer GmbHMBH
Z-1029-2018Class IIVERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM...Zimmer GmbHLPH
Z-1028-2018Class IIVERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained...Zimmer GmbHLPH
Z-1027-2018Class IIVERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR...Zimmer GmbHLPH
Z-1026-2018Class IIVERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM...Zimmer GmbHLPH
Z-1025-2018Class IIVERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained...Zimmer GmbHLPH
Z-1024-2018Class IIVERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip...Zimmer GmbHLPH
Z-1023-2018Class IIVERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip...Zimmer GmbHLPH
Z-1022-2018Class IIVersys 6 Inch Beaded Fc 12X160mm Lm Body Ext Neck Versys Beaded Fullcoat Revision Hip...Zimmer GmbHLPH
Z-1021-2018Class IIVersys 10 Inch Beaded Fc Rev 15.0X250mm Bwd Lt & Rt Versys Beaded Fullcoat Revision Hip...Zimmer GmbHLPH
Z-1020-2018Class IIVERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION...Zimmer GmbHLPH
Z-1019-2018Class IICPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHJDI
Z-1018-2018Class IICPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHJDI
Z-1017-2018Class IICPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHJWH
Z-1016-2018Class IICPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHMBH
Z-1015-2018Class IICPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer...Zimmer GmbHJDI
Z-1014-2018Class IIBIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total...Zimmer GmbHKWY
Z-0408-2018Class IIsmith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N...Smith & Nephew, Inc.HRS
Z-1190-2018Class IITapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.ZimVie US Corp LLCDZE
Z-1189-2018Class IITapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.ZimVie US Corp LLCDZE
Z-2140-2018Class IIIlmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75...Alere San Diego, Inc.DJR
Z-1223-2018Class IIVital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port...Cook Vandergrift, Inc.LJT
Z-1012-2018Class IIThe GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total...Depuy Orthopaedics Inc.KWS