Z-2135-2012 Class II Terminated
FDA device recall Z-2135-2012 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jul 17, 2012 and is designated Class II. 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… The recall status is terminated (terminated May 2, 2013). Affected quantity: 226.
Recall details
- Product Type
- Devices
- Report Date
- Aug 8, 2012
- Initiation Date
- Jul 17, 2012
- Termination Date
- May 2, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 226
Product description
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.
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
Distribution pattern
Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.
Code information
REF 0406-630-125, lot 1000037535
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2135-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026