Class 2 Device Recall InterPulse Handpiece Set With Bone Cleaning Tip and Suction Tube

• Date Initiated by Firm: October 04, 2010
• Date Posted: January 25, 2011
• Recall Status: Terminated on June 06, 2011
• Recall Number: Z-0952-2011
• Recall Event ID: 57470
• 510(K)Number: K972069
• Product Classification: Lavage, jet - Product Code FQH
• Product: The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
• Code Information: Part Number 0210-114-000E; Lot Number 09364012; Expires 12/1/2011
• Recalling Firm/ Manufacturer: Stryker Instruments Division of Stryker Corporation; 4100 East Milham Ave.; Kalamazoo MI 49001
• For Additional Information Contact: Angela Ragainis; 800-800-4236 Ext. 4354
• Manufacturer Reason for Recall: There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
• FDA Determined Cause: Packaging process control
• Action: Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge. For questions regarding this recall call (269) 323-7700.
• Quantity in Commerce: 330
• Distribution: Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK.
• 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 = FQH