Class 2 Device Recall PenAdapt"(PenAdapt is a TM of Buffalo Filter)

• Date Initiated by Firm: March 26, 2014
• Date Posted: April 24, 2014
• Recall Status: Terminated on December 11, 2014
• Recall Number: Z-1493-2014
• Recall Event ID: 67746
• Product Classification: Apparatus, exhaust, surgical - Product Code FYD
• Product: Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
• Code Information: Part Number 0702-045-027
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: 269-389-2921
• Manufacturer Reason for Recall: During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the
• FDA Determined Cause: Material/Component Contamination
• Action: On March 26, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL NOTIFICATION to their consignees via mail and email. Notification included product description, reason for recall, risk to health, and actions to be taken by the Customer/User. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Angela Ragainis/Kelly Jo Whipple 269-389-4354 / 269-389-2921 angela.ragainis@stryker.com / kellyjo.whipple@stryker.com Customers will be asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers will return affected product to Stericycle for destruction using a return label provided by Stryker or Stericycle. Upon receipt of affected product a credit will be issued to customer account. In addition, facilities are being asked to research their records for patient issues that may have been associated with the use of a recalled device, such as infection and/or inflammation.
• Quantity in Commerce: 35,310 unexpired units
• Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
• 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.