Z-1704-2011

Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552...

Name: Z-1704-2011 Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552...
Creator: Stryker Endoscopy
Published: 2010-02-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-02-25 / Terminated / root cause: design

FDA source

Stryker Endoscopy began a recall of Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555... on 2010-02-25. The reason FDA records is "The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1704-2011
Status: Terminated
Initiated: 2010-02-25
Posted: 2011-03-17
Terminated: 2011-03-18
Recalling firm: Stryker Corp.
Product: Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).
Root cause tag: design
FDA root cause: Device Design
Action: All Sales reps were notified of the recall on February 25, 2010. Urgent Device Removal advisory notices were also sent to all consignees.Device Removal letters identified the specific part numbers and lot numbers involved. Letters also list the potential risk to patients as a result of the issue. Customers are asked to inspect their inventory for part and lot numbers and quarantine any affected product. If recalled product is found, customers are to contact Stryker Customer Service at 800-624-4422 and request an RMS to send back recalled units. New units will be provided at no charge. The acknowledgement form is to be completed and returned. Questions or concerns should be directed to 408-754-2000 or e-mail at [email protected].
Quantity in commerce: 31, 014 units
Distribution: Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.
Product codes and lots: 09158FE2, 09161FE2, 09164FE2, 09170FE2, 09174FE2, 09176FE2, 09219FE2, 09226FE2, 09233FE2, 09339FE2, 09264FE2, 09204FE2, 09205FE2, 09210FE2, 09211FE2, 09217FE2, 09120FE2, 09170FE2, 09181FE2, 09181FE2P, 09175FE2, 09209FE2, and 09167FE2.

Product code GEI

K052141Class IIStryker Stiletto Electrosurgical ProbeStryker Endoscopy / cleared 2005-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)