Z-1831-2015Class II

SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic...

Name: Z-1831-2015 SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic...
Creator: Stryker Endoscopy
Published: 2015-06-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-06-03 / Terminated / root cause: design

FDA source

Stryker Endoscopy began a recall of 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... on 2015-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1831-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-06-24
Terminated: 2016-02-10
Recalling firm: Stryker Corp.
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an Urgent Medical Device Recall letter dated June 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Inform individuals within their organization who need to be aware of this device removal. 2. Review inventory of lots of part number 279-350-101 and determine if you have the affected product (all non-expired devices) in stock. Response is required. 3. If no product is found, complete acknowledgement form located on the Stryker Endoscopy recall website endorecall.stryker.com by logging in using the account number and zip code on this letter. 4. If you do have product, segregate the product and call Stryker customer service at 1-800-624-4422 Option 3 to arrange for product return and issuance of credit. For questions regarding this recall call 408-754-2664.
Quantity in commerce: 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.
Product codes and lots: Part number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1831-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-24

Product code GEI

K041810Class IISerfas Energy SystemStryker Endoscopy / cleared 2004-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)