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.

51–72 of 72

HighFDA (Devices)··2016-03-23
Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices due to insufficient sealer calibration data affecting sterility.
Product
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile intramedullary fixation rods and lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.
Product
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 in total knee arthroplasty
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0 states
ModerateFDA (Devices)··2016-03-23
Zimmer Versys Advocate Cemented Hip Implants Recalled for Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 5,013 units of Versys Advocate Cemented hip implants due to insufficient sealer calibration data. The affected sterile products were distributed nationwide.
Product
Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VER
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HighFDA (Devices)··2016-03-23
Zimmer NexGen Taper Plug Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 1,767 NexGen Taper Plugs used in total knee arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific unipolar endo femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Distal Femoral Components Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 945 units of distal femoral components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 27 consists of all product under product code: HSB 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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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns
Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting sterility.
Product
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 1181010
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ModerateFDA (Devices)··2016-03-23
Zimmer NexGen Knee Implant Recall Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling NexGen knee implant components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 5970
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.
Product
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 62000482
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ModerateFDA (Devices)··2016-03-23
Zimmer Versys Heritage Femoral Stem Recall Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 360 units of Versys Heritage Femoral Stems due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.
Product
Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400 VER
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls 34 Sterile Bone Fixation Screws
Zimmer Manufacturing B.V. is recalling 34 sterile bone fixation screws due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.
Product
Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M 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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HighFDA (Devices)··2016-03-23
Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ 78340150
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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 specific sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 1193010
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Hip Arthroplasty Femoral Heads Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR Femoral Heads used in hip arthroplasty due to insufficient sealer calibration data.
Product
Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls One-Piece Lag Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 58,320 sterile one-piece lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145 ONE
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.
Product
Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMO
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Orthopedic Screws Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 4,335 sterile orthopedic screws and bone staples due to insufficient sealer calibration data.
Product
Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM 1146040
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components
Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.
Product
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
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ModerateFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Polyethylene Patches Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile polyethylene patches due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM
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HighFDA (Devices)··2016-03-23
Zimmer Astel Femoral Head Recall Due to Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling sterile Astel femoral heads for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in t
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HighFDA (Devices)··2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM ST
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