—#91342

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K052141
Affected lot / code info: 09158FE2, 09161FE2, 09164FE2, 09170FE2, 09174FE2, 09176FE2, 09219FE2, 09226FE2, 09233FE2, 09339FE2, 09264FE2, 09204FE2, 09205FE2, 09210FE2, 09211FE2, 09217FE2, 09120FE2, 09170FE2, 09181FE2, 09181FE2P, 09175FE2, 09209FE2, and 09167FE2.

Why it was recalled

The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).

Root cause (FDA determination)

Device Design

Action the firm took

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 eprobe@stryker.com.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.

Timeline

Recall initiated: 2010-02-25
Posted by FDA: 2011-03-17
Terminated: 2011-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91342. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.