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

FDA device recall Z-0862-2012 · posted 2012-01-25 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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

Action taken

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. .

Root cause

Component change control

Status

Terminated

Product code

JDZ

Quantity affected

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

Date initiated

2011-11-30

Date posted

2012-01-25

Date terminated

2012-08-14

Location

Portage, MI

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