CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Serfas 90 degree Energy Probe recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Serfas 90 degree Energy Probe, distributed nationwide in the US. The recall was initiated on 3 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.

Quantity recalled22,063 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1831-2015
FDA event ID: 71385
Recalling firm: Stryker Endoscopy, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2015
FDA classified: 24 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

3 Jun 2015	Recall initiated by company
24 Jun 2015	Classified by FDA	+21 days
1 Jul 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it 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 lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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