Stryker Recalls RF Cannulas Due to Packaging Error
Stryker is recalling 226 units of RF Cannulas because 5mm and 10mm needles were incorrectly packaged in each other's boxes, posing a risk of thermal skin lesions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential thermal skin lesion) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 226 units of RF Cannulas, specifically the 100 mm, Curved 10 MM, 20 G model (REF 0406-630-125). The recall is due to a packaging error where 5mm needles were placed in 10mm packages and 10mm needles were placed in 5mm packages.
The affected devices are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications. The hazard arises if a clinician uses a 10mm active tip cannula in a cervical procedure, believing it to be a 5mm device. This discrepancy could result in a larger lesion creation and a potential thermal skin lesion.
The recall covers units distributed worldwide, including the United States, England, France, the Netherlands, and Switzerland. Stryker has received six complaints regarding this packaging mix-up. Clinicians and facilities should stop using the affected devices and contact Stryker for instructions on return or replacement.
The recalled product
- 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, spin
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 226
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF 0406-630-125
- lot 1000037535
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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