Events

Recall of Look Brand Black Monofilament Nylon Suture

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

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
    33771
  • Event Risk Class
    Class 3
  • Event Number
    Z-0085-06
  • Event Date Posted
    2005-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42416
  • 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, Nonabsorbable, Synthetic, Polyamide - Product Code GAR
  • Reason
    Mislabeled as double armed straight needle actually single armed straight needle.
  • Action
    On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm.

Device

Look Brand Black Monofilament Nylon Suture
  • Model / Serial
    Lot number M732780
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA.
  • Product Description
    Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.
  • Manufacturer
    Surgical Specialties Corp

Manufacturer

Surgical Specialties Corp
  • Manufacturer Address
    Surgical Specialties Corp, 100 Dennis Dr, Reading PA 19606-3776
  • Source
    USFDA