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Terminated

Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.

FDA Recall Z-0573-2008 · Posted 2008-03-05

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-11-16
Date Terminated2008-03-26
Product Quantity59 boxes of 6 units (354 total)

Reason for Recall

Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.

Firm Action

Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052141STRYKER STILETTO ELECTROSURGICAL PROBEStryker Endoscopy · 2005-10-06

Official Source

View FDA Recall →

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

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