Class 2 Device Recall Stryker

• Date Initiated by Firm: October 18, 2011
• Date Posted: November 16, 2011
• Recall Status: Terminated on July 12, 2013
• Recall Number: Z-0196-2012
• Recall Event ID: 60145
• 510(K)Number: K040369
• Product Classification: Driver, wire, and bone drill, manual - Product Code DZJ
• Product: IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
• Code Information: 06216017, 08336017, 06237017, 09021017, 06247017, 09050017, 06257017, 09083017, 06327017, 09135017, 06355017, 09197017, 07015017, 09209017, 07043017, 09231017, 07115017, 09233017, 07141017, 09246017, 07172017, 10027017, 07185017, 10046017, 07208017, 10091017, 07220017, 10148017, 07236017, 10188017, 07282017, 10217017, 07323017, 10228017, 08003017, 10251017, 08052017, 10267017, 08067017, 10327017, 08078017, 10335017, 08141017, 11004017, 08206017, 11012017, 08213017, 11098017, 08268017, 11118017, 08301017, 11159017, 08322017, 11165017.
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Angela Regainis; 269-323-7700
• Manufacturer Reason for Recall: There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli
• FDA Determined Cause: Device Design
• Action: The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated October 18, 2011 to Risk Managers, Office Managers, and Oral Surgeons. The letter described the products under recall, the problem and a series of actions to be taken. Customers were asked to immediately locate recalled products and quarantine. Products were to be shipped back to Stryker. The letter included a Business Reply Form to be faxed back to Stryker Instruments Regulatory Department, 866-521-2762. The letter instructs to forward this notification to all affected locations if the recalled products were further distributed. Customers with questions can call Stryker at 1-800-253-3210.
• Quantity in Commerce: 5,634 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Brazil, Canada, China, Germany, Greece, Hong Kong, India, Jordan, Miramar, Saudi Arabia, Singapore, Spain, Switzerland, 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 = DZJ