The Recall Desk

Manufacturer

Zimmer Manufacturing B.V.

91 recalls in our database name Zimmer Manufacturing B.V. as the manufacturing or recalling firm.

What the numbers show

Total
91
Critical
0
Severe
1
Most recent
2016-05-25

Of the 91 recalls from Zimmer Manufacturing B.V. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–91 of 91

  • ModerateFDA (Devices)·Z-1106-2016·2016-03-23

    Zimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 99 units of 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2016·2016-03-23

    Zimmer Manufacturing Recalls Bipolar Hip Liners Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells for hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2016·2016-03-23

    Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 22 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 811400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2016·2016-03-23

    Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2016·2016-03-23

    Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1166-2016·2016-03-23

    Zimmer Versys Hip Implant Recall Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,220 units of Versus hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 78710156
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.

    Product
    Product 24 consists of all product under product code: HRS 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2016·2016-03-23

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1157-2016·2016-03-23

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0590-2016·2016-01-13

    Zimmer NexGEN Tibial Components Recalled Due to Labeling Error

    Zimmer Manufacturing B.V. is recalling specific NexGEN System tibial components because a carton was mislabeled, containing a different component than indicated.

    Product
    NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0449-2016·2015-12-30

    Zimmer NexGen Knee Implant Recalled for Missing Inner Package Seal

    Zimmer Manufacturing B.V. is recalling 179 NexGen System tibial components due to missing Tyvek seals on inner packaging, reported from Thailand.

    Product
    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surfa
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0875-2015·2014-12-31

    Zimmer Recalls Trilogy Fiber Metal Acetabular Shell Due to Thread Defect

    Zimmer Manufacturing B.V. is recalling 68 units of Trilogy Fiber Metal Acetabular Shells because the polar-hole threads were found to be undersized, preventing proper attachment to surgical instruments.

    Product
    Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0824-2015·2014-12-24

    Zimmer Manufacturing Recalls Self-Tapping Bone Screws Due to Fracture Risk

    Zimmer Manufacturing B.V. is recalling 6,377 self-tapping bone screws used in hip surgery due to fractures caused by specific tool marks.

    Product
    Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2014·2014-07-16

    Zimmer EDI Periarticular Plating System Screws Recalled for Lot Commingling

    Zimmer Manufacturing B.V. is recalling 496 bone screws because two lots were commingled and packaged with incorrect labels.

    Product
    Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing p
    Category
    Medical Device
    Distribution
    Distributed nationwide