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U.S. Department of Health and Human Services

Class 2 Device Recall STIC

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  Class 2 Device Recall STIC see related information
Date Initiated by Firm July 22, 2005
Date Posted October 12, 2005
Recall Status1 Terminated 3 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.
Recalling Firm/
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 2
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 and Original Applicant = STRYKER CORP.