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Zimmer Manufacturing B.V Recalls
91 recalls on record · July 16, 2014 to May 25, 2016 · Medical Devices
Recalls by year
14
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL C
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 C
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISI
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISIO
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 C
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14M
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SEL
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 80500280
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG S
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCRE
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEA
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEA
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SE
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12M
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14M
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/
Hazard: 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.
March 23, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW
Hazard: 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.
January 13, 2016Medical DevicesFDA
Zimmer Manufacturing B.V. recalls NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Componen
Hazard: A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.
December 30, 2015Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat
Hazard: Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
December 31, 2014Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or
Hazard: Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which
December 24, 2014Medical DevicesFDA
Zimmer Manufacturing B.V. recalls Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The m
Hazard: Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .