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Terminated

Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico

FDA Recall Z-0972-2009 · Posted 2009-02-09

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-06-20
Date Terminated2009-06-22
Product Quantity2463 units

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041810SERFAS ENERGY SYSTEMStryker Endoscopy · 2004-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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