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Z-1831-2015 Class II Terminated

Recalled by Stryker Endoscopy — San Jose, CA

FDA device recall Z-1831-2015 was initiated by Stryker Endoscopy on June 3, 2015 and is designated Class II. Reason for recall: Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient. The recall status is terminated (terminated February 10, 2016). Affected quantity: 22,063 devices.

Recall Details

Product Type: Devices
Report Date: July 1, 2015
Initiation Date: June 3, 2015
Termination Date: February 10, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,063 devices

Product Description

SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the hemostasis of blood vessels.

Reason for Recall

Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to US Argentina, Australia, Bolivia, Brazil, Chile, China, Colombia, Hong Kong, India, Italy, Japan, Republic of Korea, Malaysia, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Code Information

Part number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.

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