Z-2135-2012Class II

RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk)

Name: Z-2135-2012 RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk)
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2012-07-17
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2012-07-17 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF... on 2012-07-17. FDA classified it as Class II and gives the reason as "Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2135-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Posted: 2012-08-02
Terminated: 2013-05-02
Recalling firm: Stryker Corp.
Product: RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula, as opposed
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Stryker sent an Urgent MEDICAL DEVICE Recall Notifications dated July 16, 2012 to all consignees. The letter identified the affected products, problem and actions to be taken. Customers/distributors were instructed to check their inventory and quarantine any affected product found, complete and fax the business reply form to Stryker Instruments Regulatory Department, 866-521-2762 and return all affected product using the pre-paid shipper provided. Upon receipt of the recalled product, a replacement will be issued. For questions regarding this recall please contact Stryker Instruments (Recall Coordinator) Monday-Friday 8am-5pm (EST) at 269-389-4354.
Quantity in commerce: 226
Distribution: Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.
Product codes and lots: REF 0406-630-125, lot 1000037535

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2135-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02
Z-2135-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02

Product code GXI

K032406Class IIStryker RF Electrodes and CannulaeStryker Instruments / cleared 2004-04-01

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)