Class 2 Device Recall STIC

• Date Initiated by Firm: July 22, 2005
• Date Posted: October 12, 2005
• Recall Status: Terminated on February 15, 2006
• Recall Number: Z-0034-06
• Recall Event ID: 32842
• 510(K)Number: K844214
• Product Classification: Monitor, Pressure, Intracompartmental - Product Code LXC
• Product: Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
• Code Information: Serial numbers 0428702183 through 0518008193.
• FEI Number: 1811755
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E. Milham; Kalamazoo MI 49001
• For Additional Information Contact: Jennifer Mars; 800-800-4236 Ext. 3808
• Manufacturer Reason for Recall: The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
• FDA Determined Cause: Other
• Action: Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.
• Quantity in Commerce: 473
• Distribution: Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.
• 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 = LXC