Stryker Recalls 210 RF Cannula Units Due to Packaging Error
Stryker is recalling 210 RF Cannula units because 5mm and 10mm needles were mistakenly packaged in the wrong boxes. This error could lead to thermal skin lesions if the larger tip is used in cervical procedures.
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 where a specific injury (thermal skin lesion) is identified as a potential outcome, but the source text does not report that any injuries or illnesses have actually occurred.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 210 units of the RF Cannula, 100 mm, Curved 5 MM, 20 G (REF 0406-630-115). The recall was initiated after the company received six complaints indicating that 5mm needles were placed in 10mm packages and 10mm needles were placed in 5mm packages.
The affected product is 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, believing it to be a 5mm unit, during a cervical procedure. This discrepancy can result in the creation of a larger lesion, posing a potential risk of thermal skin injury.
The recalled units were distributed worldwide, including the United States, England, France, the Netherlands, and Switzerland. Clinicians and facilities should stop using the affected RF Cannulae and contact Stryker for instructions on return or replacement.
The recalled product
- 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, spina
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 210
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 0406-630-115
- lot 1000035056
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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