—#105884

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

FDA product code: JDZ — Mixer, Cement, For Clinical Use
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K032945, K912190
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Component change control

Action the firm took

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. .

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Nationwide Distribution including FL, PA, NY, OH, IL, KY, MT, WA, CA, MO, HI, IN, SC, MS, WV, KS, TX, and WY

Timeline

Recall initiated: 2011-11-30
Posted by FDA: 2012-01-25
Terminated: 2012-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.