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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthobiologics Aliquot Plunger Delivery System, 4", Part Number 2090501

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  Class 2 Device Recall Stryker Orthobiologics Aliquot Plunger Delivery System, 4", Part Number 2090501 see related information
Date Initiated by Firm November 10, 2012
Date Posted May 24, 2013
Recall Status1 Terminated 3 on October 29, 2014
Recall Number Z-1389-2013
Recall Event ID 63204
Product Classification Injector, vertebroplasty (does not contain cement) - Product Code OAR
Product Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501

Product Usage:
Facilitate placement of bone cement in weakened or diminished bone
Code Information Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002 
Recalling Firm/
Manufacturer		 Orthovita, Inc., dBA Stryker Orthobiologics.
45 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Customer Support
610-640-1775
Manufacturer Reason
for Recall		 There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
FDA Determined
Cause 2		 Labeling design
Action Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Quantity in Commerce 411
Distribution USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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