RF Cannula — Class II medical device recall Z-2134-2012
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2012-08-08, distributed nationwide. Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed
| Recall number | Z-2134-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2012-07-17 |
| Classified | 2012-08-02 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, FR, GB, NL |
| Quantity | 210 |
| Lot numbers | 1000035056 |
| Model numbers | 0406-630-115, 0406-630-115RX |
Product
RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2134-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.