Class 2 Device Recall CORE Universal Driver

• Date Initiated by Firm: July 01, 2013
• Date Posted: July 16, 2013
• Recall Status: Terminated on September 16, 2013
• Recall Number: Z-1741-2013
• Recall Event ID: 65456
• 510(K)Number: K040300
• Product Classification: Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
• Product: CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
• Code Information: Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kara Spath; 269-323-7700
• Manufacturer Reason for Recall: The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100
• FDA Determined Cause: Process change control
• Action: The firm, Stryker Instruments, sent emails beginning May 30, 2013 "URGENT MEDICAL DEVICE CORRECTION" letter dated July 1, 2013 to its customers. The letter identified the device, the reason for the recall, possible adverse events and actions to be taken. The customers were instructed to immediately review this letter, locate the units listed, complete and return the business reply form via FAX to 866-521-2762; or email Kara.spath@stryker.com; if you have further distributed this product, please forward this letter and the attached Business Reply Form to all affected locations. After receiving this form, Stryker will send you a pre-paid shipper to send your affected device(s)back to Stryker to be reprogrammed with the correct specifications. Send back all affected devices using the pre-paid shipper provided to you by Stryker. If you require a loaner, please contact the Stryker Service Department to arrange for a loaner at 888-308-1983. For questions regarding this recall please Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-4518 / 269-389-3808 kara.spath@stryker.com / jennifer.mars@stryker.com.
• Quantity in Commerce: 11
• Distribution: Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
• 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 = ERL