Class 2 Device Recall Sagittal Blade 18.0X0.97X90MM

• Date Initiated by Firm: August 17, 2016
• Date Posted: October 18, 2016
• Recall Status: Terminated on March 29, 2017
• Recall Number: Z-0112-2017
• Recall Event ID: 75018
• Product Classification: Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
• Product: Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090; ; Product Usage:; Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)
• Code Information: Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kelly Jo Davis; 269-389-2921
• Manufacturer Reason for Recall: Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.
• FDA Determined Cause: Packaging
• Action: Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM, product number 6118-097-090, lot number 16029017, due to a breach in the packaging causing a breach in sterility. There is a potential for a bone or soft tissue infection which may require medical or surgical intervention. Customer notices were issued via certified mail on 08/17/2016. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many Sagittal Blades from the affected lot (listed above) are at your facility. Quarantine and discontinue use of the recalled Sagittal Blades. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if customers dont have any affected product on hand. Note: Customer signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If customers have further distributed this product, please forward the recall letters and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. 6. If the BRF for customer facilities indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. 7. Upon receipt of the recalled product, replacement product will be shipped to customer accounts. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis, 269-389-2921, kellyjo.davis@stryker.com
• Quantity in Commerce: 225
• Distribution: US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
• 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.