The Recall Desk

Manufacturer

Biomet

24 recalls in our database name Biomet as the manufacturing or recalling firm.

What the numbers show

Total
24
Critical
0
Severe
0
Most recent
2020-06-24

Of the 24 recalls from Biomet 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.

1–24 of 24

  • HighFDA (Devices)·Z-2363-2020·2020-06-24

    Biomet Recalls Screw Instrument Tray Due to Sterilization Validation Failure

    Biomet is recalling 705 units of Screw Instrument Trays because the device and tray failed steam sterilization process validation testing.

    Product
    Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2020·2020-06-24

    Biomet Outer Sheath Recalled Due to Failed Sterilization Validation Testing

    Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 because the device and tray failed steam sterilization validation testing.

    Product
    Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2318-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History

    Biomet is recalling 78 units of A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2303-2020·2020-06-17

    Biomet 6.5 Cannulated Screw Tap Recalled for Incomplete Design History

    Biomet is recalling 6.5 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

    Product
    Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2324-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Design History Deficiencies

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because it was distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2020·2020-06-17

    Biomet A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve Recalled

    Biomet is recalling A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2310-2020·2020-06-17

    Biomet A.L.P.S. T15 Multi-Directional Locking Screw Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. T15 Multi-Directional Locking Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Locking Pegs Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Pegs 60mm because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2020·2020-06-17

    Biomet Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2322-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling specific lots of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2020·2020-06-17

    Biomet A.L.P.S. Cortical Screw Recalled for Incomplete Design History

    Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2314-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design Files

    Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Drill Bit Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Calibrated Drill Bits because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because units were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling 16 units of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2304-2020·2020-06-17

    Biomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files

    Biomet is recalling 8.0 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

    Product
    Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide