Events

Recall of Device Recall Bone Void Filler

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

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
    56858
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-2011
  • Event Initiated Date
    2010-08-26
  • Event Date Posted
    2010-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94674
  • 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
    Filler, bone void, synthetic peptide - Product Code NOX
  • Reason
    The firm's quality control testing determined that a separation was occurring between the flowable carrier and the b-tricalcium phosphate within some of the product syringes.
  • Action
    Theken Spine Llc sent Recall Notification Letters dated August 26, 2010, to all customers. One (1) document, titled an 'Urgent Product Recall Notification' letter was addressed: 'ATTENTION; PRODUCT RECALL COORDINATOR/RISK MANAGER.' The other letter was titled: 'RECALL NOTIFICATION.' The recall letters were accompanied by an attached 'Recall Acknowledgement and Return Form' and were sent out via Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. The letters requested that the customers review their product in inventory and identify any product remaining from the affected lot numbers; part numbers; and/or item names for immediate return of these items to the recalling firm. The letters also asked that the customer complete and return the attached Recall Acknowledgement and Return form according to the instructions provided on the form. In addition, the 'RECALL NOTIFICATION' letter instructed the distributor/customers provide information concerning their sub-account customers to Theken Spine so they could issue a Recall Notification letter to these customers as well. To obtain instructions from the recalling firm concerning product return and issuance of credit, customers were instructed to call (866) 942-8698. For questions regarding this recall call (330) 825-8258.

Device

Device Recall Bone Void Filler
  • Model / Serial
    The products are identified with the following Model Numbers and Trade Names:   FormPutty - Model #50-07-0050 FormPutty - Model #-50-07-0100 SBvFShape - Model #-725-7010 SBvFShape - Model #-725-7025 SBvFShape - Model #-725-7050 SBvF Shape - Model #-725-7100 SynFlow - Model #-05-7100-010 SynFlow - Model #-05-7100-025 SynFlow - Model #-05-7100- 050 SynFlow - Model #-05-7100-100 TheriGraft TCP Putty - Model #107010 TheriGraft TCP Putty - Model #107025  TheriGraft TCP Putty - Model #107050 TheriGraft TCP Putty - Model #107100 Valeo BP - Model #817010 Valeo BP - Model #817025 Valeo BP - Model #817050 Valeo B - Model #817100 X-Putty - Model #TS0005 X-Putty - Model #TS0006  The product are also identified with the following Lot Numbers and Expiration Dates: A09I02XY - Expiration Date: 2011-09; A09I03XY - Expiration Date: 2011-09; A09I04XY - Expiration Date: 2011-09; A09K01XY - Expiration Date: 2011-11; A09L01XY - Expiration Date: 2011-12; A10A01XY, Expiration Date: 2012-01; and A10C04XY - Expiration Date: 2012-03. Please Note: XY denotes a 'letter number' combination that specified the size and packaging sequence for the specific unit(s).
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - including UT, SD, TX, AL, PA, CA, MI, OH, NJ, NH, MD, ID, FL, LA, NM, TN, IA, and OR.
  • Product Description
    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. || The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).
  • Manufacturer
    Theken Spine Llc

Manufacturer

Theken Spine Llc
  • Manufacturer Address
    Theken Spine Llc, 1800 Triplett Blvd, Akron OH 44306-3311
  • Manufacturer Parent Company (2017)
    Theken Spine Llc
  • Source
    USFDA