Events

Recall of Device Recall MANOS EX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thayer Intellectual Property, 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
    75630
  • Event Risk Class
    Class 2
  • Event Number
    Z-0702-2017
  • Event Initiated Date
    2016-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150962
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The firm failed to notify current customers of ifu update/warning. during a recent fda inspection, it was discovered that thayer intellectual property, inc. had revised their ifu to include a warning not to bend, deform or otherwise modify any part of the device. the warning was added as a result of a maude report filed in december 2014 where a piece of the manos ex broke during use and was left in the patient's hand. the patient suffered a tendon injury and an additional surgery was required to remove the broken piece of the device and repair the tendon. fda inspection found that while the firm had updated their ifu, they had not notified customers who had been shipped the device with the older version that did not include the warning. risk: it is important for manos ex users to be aware that bending, deforming, or modifying the device could result in device breakage which could impact patient safety and device performance.
  • Action
    Thayer sent an Urgent Medical Device Correction letters dated November 4, 2016 by Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were asked to check if any of the affected lots were still available, and if so, to change out the IFU with version 5. For questions call 415-923-9375.

Device

Device Recall MANOS EX
  • Model / Serial
    LOT 1055337, Expiry 4/01/2015; LOT 1071800. Expiry 5/1/2017; LOT 1102580; Expiry 8/1/2017; LOT 1154179; Expiry 12/01/2017.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID, SD, IN, and GA.
  • Product Description
    MANOS EX (CAT#TY-12-101) || Product Usage: || Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.
  • Manufacturer
    Thayer Intellectual Property, Inc.

Manufacturer

Thayer Intellectual Property, Inc.
  • Manufacturer Address
    Thayer Intellectual Property, Inc., 1331 N California Blvd Ste 320, Walnut Creek CA 94596-4563
  • Manufacturer Parent Company (2017)
    Thayer Intellectual Property Inc.
  • Source
    USFDA