Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 8, 2012
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.
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 ac…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Instruments Div. of Stryker Corporation recalled RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) … - a moderate-severity action.
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) … was recalled by Stryker Instruments Div. of Stryker Corporation in August 8, 2012. Reason: Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed…. Check the official notice for the remedy. Verify recall #Z-2135-2012 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this moderate-severity FDA Devices recall-Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed….
- Moderate
- severity level
- 226 units
- affected scope
- Class II
- classification
- August 8, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2135-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2135-2012) was formally reported on August 8, 2012, with the manufacturer initiating the action on July 17, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 226.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
226
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2135-2012 |
| Date reported | August 8, 2012 |
| Date initiated | July 17, 2012 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 226 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2135-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 226.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2012. Severity: Moderate. Recall number: Z-2135-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2135-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 8, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.