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U.S. Department of Health and Human Services

Class 2 Device Recall Shaver Handpiece Sterilization Tray

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  Class 2 Device Recall Shaver Handpiece Sterilization Tray see related information
Date Initiated by Firm May 19, 2014
Date Posted June 25, 2014
Recall Status1 Terminated 3 on May 07, 2015
Recall Number Z-1872-2014
Recall Event ID 68405
510(K)Number K941333  
Product Classification Arthroscope accessory - Product Code HRX
Product Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Code Information Part Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329. 
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoefer
408-754-2664
Manufacturer Reason
for Recall		 STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Device Correction letters were sent on May 23, 2014 to all users by certified mail. Internation sites will receive notification and be responsible for contacting customers.
Quantity in Commerce 1992 trays
Distribution Worldwide Distribution.
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 = HRX and Original Applicant = Stryker Endoscopy
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