FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: 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.
- Recall number
- Z-1831-2015
- Recalling firm
- Stryker Endoscopy
- 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.
- Status
- Terminated
- Initiated
- 2015-06-03
- Posted
- 2015-06-24
- Terminated
- 2016-02-10
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Part number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.
- 510(k) numbers
- ["K041810"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28