Devices

Device Recall Mentor

  • Model / Serial
    Lot numbers 269402 and 264358
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.
  • Product Description
    Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
  • Manufacturer
    Mentor Texas, Inc
  • 1 Event

Manufacturer

Mentor Texas, Inc
  • Manufacturer Address
    Mentor Texas, Inc, 3041 Skyway Cir N, Irving TX 75038-3500
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall MENTOR MemoryGel Sizer
  • Model / Serial
    6790747-030, 6684051-002, 6685063-013, 6728126-044, 6822437-031, 6685063-011, 6728128-035, 6702298-031, 6838011-018, 6733863-003, 6733863-017, 6701421-023, 6696938-022, 6824389-004, 6719893-016, 6687714-031, 6834854-016, 6839585-001, 6849927-019, 6675404-028, 6684051-031, 6803156-029, 6838011-020, 6825406-014, 6751554-012, 6741590-026, 6830995-006, 6721250-014, 6694754-031, 6707932-006, 6789276-002, 6790619-029, 6821980-010, 6853040-025, 6691833-020, 6715539-004, 6836766-012, 6683549-030, 6703183-005, 6789532-021, 6789191-001, 6848592-012, 6790747-028, 6833028-030, 6723961-006, 6716622-011, 6742458-008, 6684051-026, 6685067-008, 6703784-036, 6748082-029, 6748820-019, 6822436-028, 6827017-004, 6829287-016, 6834856-021, 6825200-001, 6701421-034, 6716223-011, 6794993-017, 6723958-007, 6723958-011, 6723957-042.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
  • Product Description
    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
  • Manufacturer
    Mentor Texas, LP.
Device Recall Mentor MemoryGel Breast Implant
  • Model / Serial
    7316994
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.
  • Product Description
    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
  • Manufacturer
    Mentor Texas, LP.
Device Recall MENTOR Sterile Saline Mammary Volume Sizer
  • Model / Serial
    Part Number (PN) 351-3380SZ Lot Number 6830722
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
  • Product Description
    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer || REF 351-3380SZ 380 cc LOT 6830722. || Product Usage: || This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
  • Manufacturer
    Mentor Texas, LP.
Device Recall Mentor Aseptic Transfer Set
  • Model / Serial
    Aseptic Transfer Sets: All lots.  Syringes: Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. Product also sent to the following countries: Australia, Canada, Costa Rica, Korea, New Zealand and South Africa.
  • Product Description
    Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
  • Manufacturer
    Mentor Texas, Inc