—#66216

Product

SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K041810
Affected lot / code info: Lot Numbers: 06361AE2 06362AE2 07004AE2 07008AE2 07010AE2 07012AE2 07016AE2 07017AE2 07018AE2 07022AE2 07025AE2 07026AE2 07029AE2 07031AE2 07036AE2 07038AE2 07043AE2, and 07044AE2

Why it was recalled

Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Consignees were mailed an Urgent Device Removal Recall notice, dated April 27, 2007. International subsidiaries will receive the recall notice and they will distribute to their consignees. Product is to be returned as a recall.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and WV; INTERNATIONAL: Affiliated Stryker Distribution Companies: Sweden (for Scandinavia area), Australia, Canada, France, Germany, Greece, South Africa, Iberia, Italy, Mexico, Portugal, Switzerland (2 separate sites), and The UK

Timeline

Recall initiated: 2007-04-26
Posted by FDA: 2008-01-17
Terminated: 2008-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66216. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.