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U.S. Department of Health and Human Services

Class 2 Device Recall Omega Compression Screw System

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  Class 2 Device Recall Omega Compression Screw System see related information
Date Initiated by Firm January 25, 2005
Date Posted September 16, 2008
Recall Status1 Terminated 3 on September 24, 2008
Recall Number Z-1865-2008
Recall Event ID 48206
510(K)Number K850886  K872223  K922295  K930156  K955306  
Product Classification Multiple component nail/blade/plate combination fixation appliance - Product Code KTT
Product Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plates, and compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric) and/or distal third of the femur (supracondylar area. These components are now made available in sterile packaging.
Code Information Catalog Number: 3362-0-404 Lot code: E00985
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Colleen O'Meara
201-831-5000
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.
FDA Determined
Cause 2		 Process control
Action Stryker branches and agencies were notified by letter on January 25, 2005. Letters to branches were notified of the packaging error and asked that all inventory location be examined to identify product. Product was to be returned to Stryker. If the product was further distributed, letters were provided to be sent to hospital OR Supervisors. A reconciliation form was also included and asked to be completed and returned. For information on this recall contact Rita Intorella at 201-831-5825.
Quantity in Commerce 20 units
Distribution To Stryker branches and hospitals nationwide.
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 = KTT and Original Applicant = HOWMEDICA CORP.
510(K)s with Product Code = KTT and Original Applicant = PFIZER HOSPITAL PRODUCTS GROUP, INC.
510(K)s with Product Code = KTT and Original Applicant = PFIZER, INC.
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