Events

Recall of Device Recall Phantom Fiber Biofiber Sutures

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tornier, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79373
  • Event Risk Class
    Class 2
  • Event Number
    Z-1374-2018
  • Event Initiated Date
    2018-02-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162146
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Suture, recombinant technology - Product Code NWJ
  • Reason
    Data has shown that degradation of a raw material used in phantom fiber may occur more quickly than expected if improperly stored. this may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
  • Action
    The firm, Wright, sent an "Urgent Field Safety Notice" letter by email on 02/08/2018. The firm followed up with a letter on April 02, 2018 disseminated by FedEx Priority mail to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following actions: " Cease using the affected devices immediately. " Medical facilities are to determine if any of the recalled implants are on hand, and return affected implants immediately to Wright Medical. "Review the notice and complete the Acknowledgement Section Attachment C to signify that your facility has been informed of this Field Safety Notice (Recall). " Return the completed Acknowledgement to Wright Medical via email to: FieldAction@wright.com within five (5) working days of this notice. "Contact customer service at 1-888-494-7950 to facilitate any product returns. For any inquiries regarding the Phantom Fiber Field Safety Notice (Recall) contact: Wright Medical Quality Systems Manager by Email: FieldAction@wright.com or Phone: 952.683.7482.

Device

Device Recall Phantom Fiber Biofiber Sutures
  • Model / Serial
    All lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Fornier Phantom Fiber(TM) Sutures: || Item Number Description || SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES || SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES || SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES || SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES || SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE || SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED || SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE || SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED || SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET || SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED || SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET || SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED || SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET || SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET || Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc
  • Manufacturer Address
    Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA