Recall Z-1831-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
| Date | Jun 24, 2015 (initiated Jun 3, 2015) |
| Status | Terminated |
| 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 en |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041810 | SERFAS ENERGY SYSTEM Stryker Endoscopy, Dec 21, 2004 |