The Recall Desk

Manufacturer

Biomet Microfixation, LLC

19 recalls in our database name Biomet Microfixation, LLC as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2017-05-24

Of the 19 recalls from Biomet Microfixation, LLC 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.

1–19 of 19

  • ModerateFDA (Devices)·Z-2073-2017·2017-05-24

    Biomet Microfixation Recalls Surgical Trays Due to Part Number Mismatch

    Biomet Microfixation is recalling 33 TraumaOne System Surgical Trays because the part number on the lid differs from the base.

    Product
    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0136-2016·2015-10-28

    Biomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled

    Biomet Microfixation is recalling 37 Neuro Combo Set Cases because the lids require excessive force to open.

    Product
    Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0137-2016·2015-10-28

    Biomet Thinflap System Cases Recalled Due to Lid Opening Difficulty

    Biomet Microfixation is recalling 5 Thinflap System Cases because the lids require excessive force to open.

    Product
    Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0518-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0520-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0514-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0517-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0511-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0516-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0513-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0522-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0510-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0519-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0521-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0509-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0512-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 total temporomandibular joint replacement systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2566-2014·2014-09-10

    Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up

    Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.

    Product
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replace
    Category
    Medical Device
    Distribution
    0 states