Z-0862-2012

Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box...

Name: Z-0862-2012 Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2011-11-30
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2011-11-30 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI... on 2011-11-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0862-2012
Status: Terminated
Initiated: 2011-11-30
Posted: 2012-01-25
Terminated: 2012-08-14
Recalling firm: Stryker Corp.
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
Product code: JDZ Mixer, Cement, For Clinical Use
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
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: 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

Product code JDZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)