Events

Recall of Device Recall Flower Orthopedics Variable Angle Locking Peg

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

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
    70578
  • Event Risk Class
    Class 2
  • Event Number
    Z-1314-2015
  • Event Initiated Date
    2015-02-16
  • Event Date Posted
    2015-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134073
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Locking pegs were not locking during distal radius procedures. there has been one (1) report of revision surgery scheduled to remove a loosened peg.
  • Action
    On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.

Device

Device Recall Flower Orthopedics Variable Angle Locking Peg
  • Model / Serial
    All lots of Catalog Numbers:  FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
  • Product Description
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. || The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
  • Manufacturer
    Flower Orthopedics Corporation

Manufacturer

Flower Orthopedics Corporation
  • Manufacturer Address
    Flower Orthopedics Corporation, 100 Witmer Rd Ste 280, Horsham PA 19044-2647
  • Manufacturer Parent Company (2017)
    Flower Orthopedics Corp.
  • Source
    USFDA