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U.S. Department of Health and Human Services

Class 2 Device Recall External Compression Device

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  Class 2 Device Recall External Compression Device see related information
Date Initiated by Firm August 30, 2010
Date Posted November 09, 2010
Recall Status1 Terminated 3 on August 21, 2012
Recall Number Z-0330-2011
Recall Event ID 56800
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product External Compression Device; 1 unit per package
Stryker Trauma GmbH;
Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430
Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw) and will push the screw in distal direction. As the cross screw is screwed into the bone of the patient, the bone fragment will be moved too is distal direction. Finally both sides of the bone fracture will be pressed together - compression is now applied to the fracture side.
Code Information Catalog Number: 1806-1601; Lot code: K228113
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Richard Wolyn
201-972-2100
Manufacturer Reason
for Recall		 Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible.
FDA Determined
Cause 2		 Other
Action Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice. A Stryker representative would contact the customer with details for return of the product. For any questions regarding this recall call (201) 972-2100.
Quantity in Commerce 11
Distribution Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX
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.
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