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U.S. Department of Health and Human Services

Class 2 Device Recall SERFAS 90 degree Energy Probe, Part Number 279350101

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  Class 2 Device Recall SERFAS 90 degree Energy Probe, Part Number 279350101 see related information
Date Initiated by Firm June 03, 2015
Date Posted June 24, 2015
Recall Status1 Terminated 3 on February 10, 2016
Recall Number Z-1831-2015
Recall Event ID 71385
510(K)Number K041810  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information Part number 279-350-101; All non expired product; lot numbers 13128AE2 through 14337AE2.
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
408-754-2664
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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