PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 1, 2015 Initiated: June 3, 2015 #Z-1831-2015

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.

Details

Recalling Firm
Stryker Endoscopy
Units Affected
22,063 devices
Distribution
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.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Endoscopy. Units affected: 22,063 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1831-2015.