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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PCD Precision System 13G Needle with Spineplex

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  Class 2 Device Recall Stryker PCD Precision System 13G Needle with Spineplex see related information
Date Initiated by Firm November 30, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on August 14, 2012
Recall Number Z-0862-2012
Recall Event ID 60586
510(K)Number K032945  K912190  
Product Classification Mixer, cement, for clinical use - Product Code JDZ
Product Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI
Part Number: 0505-585-000, Lot:11223012

13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011
13G Bevel Tip Stylet - PIN 0306-131-012

The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy
Code Information Part Number 0505-585-000, Lot 11223012  13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Angela Ragainis
Manufacturer Reason
for Recall
Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. In addition, if the stylet needs to be changed and the additional stylet that comes in the package is used, this additional stylet is one inch longer than the needle. which could l
FDA Determined
Cause 2
Component change control
Action Stryker sent an Urgent Recall Notification letter dated December 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If product was further distributed, customers should forward the recall notification letter and the attached Business Reply Form (BRF) to all affected locations. Immediately check inventory and quarantine any affected product found. Mark product as "RECALLED PRODUCT". Indicate on the BRF the quantity of affected PCD kits they are returning and fill in the form completely. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact them to coordinate the return of all affected product that they have on hand. For questions regarding this recall call 269-389-4354. .
Quantity in Commerce 11 kits of the 192 manufactured contain the wrong needle size.
Distribution Nationwide Distribution including FL, PA, NY, OH, IL, KY, MT, WA, CA, MO, HI, IN, SC, MS, WV, KS, TX, and WY
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.
510(K) Database 510(K)s with Product Code = JDZ and Original Applicant = STRYKER CORP.