The Recall Desk

Manufacturer

Integra LifeSciences Corporation

29 recalls in our database name Integra LifeSciences Corporation as the manufacturing or recalling firm.

What the numbers show

Total
29
Critical
0
Severe
0
Most recent
2016-09-21

Of the 29 recalls from Integra LifeSciences Corporation 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.

26–29 of 29

  • HighFDA (Devices)·Z-0559-2013·2012-12-26

    Integra Recalls Mayfield Skull Clamps Due to Performance Issues

    Integra LifeSciences is recalling eight Mayfield Composite Series Skull Clamps (Model A3059) due to product performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2013·2012-12-26

    Integra LifeSciences Recalls Mayfield Composite Series Base Units

    Integra LifeSciences is recalling Mayfield Composite Series Base Units and Skull Clamps due to performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2428-2012·2012-09-26

    Integra CRW Precision Arc and HRAIM Head Ring Assembly Recalled

    Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.

    Product
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2012·2012-09-26

    Integra HRAIM Head Ring Assembly Recalled for T-Handle Seating Issue

    Integra LifeSciences is recalling HRAIM Head Ring Assemblies because a T-handle screw may prevent the CRW stereotactic system from seating properly.

    Product
    Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Integra LifeSciences

company in Plainsboro Center, United States

Country
United States
Founded
1989

Official website

Source: Wikidata (Q30283982), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.