Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryke
FDA device recall Z-0972-2009 · posted 2009-02-09 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.
- Action taken
- On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of receipt" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2463 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2008-06-20
- Date posted
- 2009-02-09
- Date terminated
- 2009-06-22
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERFAS ENERGY SYSTEM (K041810) | Stryker Endoscopy | 2004-12-21 |