The Recall Desk

Manufacturer

Stanmore Implants Worldwide Ltd.

8 recalls in our database name Stanmore Implants Worldwide Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2017-09-13

Of the 8 recalls from Stanmore Implants Worldwide Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–8 of 8

  • HighFDA (Devices)·Z-3104-2017·2017-09-13

    Stanmore JTS Distal Femoral Implant Recalled Due to Extension Failure

    Stanmore Implants Worldwide Ltd. is recalling 15 JTS Distal Femoral Extendible Implants because they may fail to extend as intended due to incorrect orientation or settings.

    Product
    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0822-2017·2016-12-28

    Stanmore Implants Recalls Punctured Femoral Shaft Components

    Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging reported by customers.

    Product
    Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0821-2017·2016-12-28

    Stanmore Implants Recalls Tibial Components Due to Packaging Puncture

    Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.

    Product
    Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2017·2016-12-28

    Stanmore Implants Recalls DF Coated Integral Shaft and Stem Components

    Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components due to packaging punctures reported by customers.

    Product
    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or defici
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0823-2017·2016-12-28

    Stanmore Implants Recalls Punctured Femoral Stem Components

    Stanmore Implants Worldwide Ltd. is recalling 15 femoral stem components because customer inquiries reported that the device stem punctured the packaging pouch.

    Product
    Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if dise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2017·2016-12-28

    Stanmore Tibial Component Fixed Hinge Recall Due to Pouch Puncture

    Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Short due to punctured packaging.

    Product
    Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2016·2016-08-24

    Stanmore METS SMILES Total Knee Replacement Recall for Fit Issues

    Stanmore Implants Worldwide Ltd. is recalling 3 units of METS SMILES Total Knee Replacements because the femoral plateau plates may not fit the intended mating component.

    Product
    METS SMILES Total Knee Replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1623-2016·2016-05-18

    Stanmore Distal Femoral Replacement Recalled for Incorrect Component

    Stanmore Implants Worldwide Ltd. is recalling one custom-made distal femoral replacement implant due to the use of an incorrect component during manufacturing.

    Product
    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
    Category
    Medical Device
    Distribution
    1 state