FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: 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.
- Recall number
- Z-2135-2012
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-07-17
- Posted
- 2012-08-02
- Terminated
- 2013-05-02
- Reason
- 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
- 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
- 226
- Distribution
- Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.
- Lot, serial or model codes
- REF 0406-630-125, lot 1000037535
- 510(k) numbers
- ["K032406"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28