Year

2016 Product Recalls

6,515 product recalls issued in 2016 across CPSC, FDA, and USDA datasets.

6,515 recalls
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constra...
Medical Implants·4,844 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 4748270...
Medical Implants·60 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FE...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NE...
Medical Devices·29,525 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained...
Medical Implants·42,064 affected·Jan 11, 2016
High RiskFDA
Leica Microsystems, Inc.
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the F...
Surgical Devices·381 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the followin...
Medical Implants·1,305 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 IN...
Medical Implants·268 affected·Jan 11, 2016
High RiskFDA
Arthrex, Inc.
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture ...
Medical Implants·117 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 B...
Medical Devices·87,341 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MG...
Medical Devices·3,696 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/...
Medical Devices·512 affected·Jan 11, 2016
High RiskFDA
Horiba Instruments Inc
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human s...
Diagnostic Devices·216 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029...
Medical Devices·112,588 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product...
Medical Implants·2 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VER...
Medical Implants·5,538 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 A...
Medical Implants·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For ...
Medical Devices·400 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 ...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use i...
Medical Devices·49 affected·Jan 11, 2016
High RiskFDA
Horiba Instruments Inc
ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, p...
Diagnostic Devices·216 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERS...
Medical Devices·5,013 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee...
Medical Devices·1,767 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product U...
Medical Implants·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use i...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the followin...
Medical Implants·101 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INT...
Medical Implants·1,777 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DI...
Medical Implants·945 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3....
Medical Implants·109 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401...
Medical Implants·99 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 ...
Medical Devices·2,239 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD ...
Medical Devices·0 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including ...
Medical Implants·194 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018...
Medical Implants·56 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for c...
Medical Implants·289 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/...
Medical Devices·1,622 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/...
Medical Devices·1,102 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 4748200280...
Medical Implants·154 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIP...
Medical Devices·8,773 affected·Jan 11, 2016
High RiskFDA
Horiba Instruments Inc
ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in pl...
Diagnostic Devices·216 affected·Jan 11, 2016
High RiskFDA
Varian Medical Systems, Inc.
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning...
Medical Devices·9,499 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer vari...
Medical Implants·13,483 affected·Jan 11, 2016
High RiskFDA
Medtronic Neuromodulation
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for...
Medical Devices·51,138 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MIN...
Medical Implants·3,190 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERS...
Medical Devices·13 affected·Jan 11, 2016
High RiskFDA
Horiba Instruments Inc
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum...
Diagnostic Devices·216 affected·Jan 11, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FR...
Medical Implants·3,500 affected·Jan 11, 2016
High RiskFDA
Zimmer Biomet, Inc.
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the Mu...
Medical Implants·72,806 affected·Jan 11, 2016