FDA (Devices) recall action 72900

Zimmer Manufacturing B.V. recalled 72 products on 2016-03-23

The FDA (Devices) publishes a recall like this one as 72 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 72 pages.

Products: 72
Announced: 2016-03-23
Critical: 0
Units: 665,035

Why these products were recalled

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 72

HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns
Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 1
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HighFDA (Devices)··2016-03-23
Zimmer NexGen Option Stemmed Tibia Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen Option Stemmed Tibia components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 5986057
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Hip Stems Due to Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling specific hip stem products because of insufficient sealer calibration data for items packaged in Building II between August 2010 and April 2013.
Product
Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 119 Sterile Bone Fixation Appliances
Zimmer Manufacturing B.V. is recalling 119 sterile bone fixation appliances due to insufficient sealer calibration data. The affected products were packaged between August 2010 and April 2013.
Product
Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PRO
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Hip Arthroplasty Stems Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile cemented femoral stems for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Trilogy Acet Shell Hip Implant Components
Zimmer Manufacturing B.V. is recalling 400 units of Trilogy Acet Shell hip implant components due to insufficient sealer calibration data.
Product
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
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ModerateFDA (Devices)··2016-03-23
Zimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 39 sterile precoat tibia plates used in total knee arthroplasty due to insufficient sealer calibration data.
Product
Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
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HighFDA (Devices)··2016-03-23
Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.
Product
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Appliances Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 1,209 units of sterile metallic bone fixation appliances due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 8114000
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ModerateFDA (Devices)··2016-03-23
Zimmer Herbert Bone Screws Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 4,018 units of Herbert bone screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0M
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Compression Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 3,415 sterile compression screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 471
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Anti-Rotation Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling seven ITST Anti-Rotation Screws because of insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
Product
Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product Us
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ModerateFDA (Devices)··2016-03-23
Zimmer Zimtron Hip Arthroplasty Heads Recalled for Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 226 sterile Zimtron hip arthroplasty heads due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.
Product
Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling specific lots of sterile 4.5 x 26 Cortical Screws due to insufficient sealer calibration data during packaging.
Product
Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Knee Arthroplasty Bone Screws
Zimmer Manufacturing B.V. is recalling 3,696 sterile MGII Knee Self-Tap Bone Screws due to insufficient sealer calibration data.
Product
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 5110070
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Intramedullary Nails Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 1,102 sterile intramedullary nails distributed nationwide. The recall is due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
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/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 2240010
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 12 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.
Product
Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that c
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Distal Femoral Components for Sterility Concerns
Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total hip arthroplasty due to insufficient sealer calibration data.
Product
Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508
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ModerateFDA (Devices)··2016-03-23
Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling sterile modular hip cups due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 6110050
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 1,394 sterile intramedullary fixation rods and reconstruction screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 REC
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ModerateFDA (Devices)··2016-03-23
Zimmer Versys Cemented Femoral Stem Recall for Calibration Issues
Zimmer Manufacturing B.V. is recalling 13 Versys Cemented Femoral Stems due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
Product
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
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HighFDA (Devices)··2016-03-23
Zimmer Free-Lock Tube and SCP Plate Recall for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 285 units of Free-Lock Tube & SCP Plate devices due to insufficient sealer calibration data affecting sterility.
Product
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 1181145
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 4,752 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 I
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
Product
Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603
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ModerateFDA (Devices)··2016-03-23
Zimmer HGP II Acetabular Cup Recall Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 2,236 HGP II Acetabular Cup components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 6624065
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