—#77412

Product

Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; 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: K041810
Affected lot / code info: 08065AE2, 08066AE2, 08070AE2, 08079AE2, 08084AE2, 08086AE2, 08080AE2, 08085AE2, 08087AE2, 08088AE2, 08129AE2, 08128AE2, 08130AE2, 08136AE2, 08137AE2, 08140AE2, 08149AE2, 08154AE2, and 08157AE2

Why it was recalled

The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2008-06-20
Posted by FDA: 2009-02-09
Terminated: 2009-06-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77412. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.