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U.S. Department of Health and Human Services

Class 2 Device Recall S TBone Plate; M TCompression Plate;

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  Class 2 Device Recall S TBone Plate; M TCompression Plate; see related information
Date Initiated by Firm May 26, 2006
Date Posted February 16, 2011
Recall Status1 Terminated 3 on December 08, 2014
Recall Number Z-1334-2011
Recall Event ID 50094
510(K)Number K062498  
Product Classification Plate, fixation bone - Product Code HRS
Product S T-Bone Plate;
M T-Compression Plate;
Manufactured and Distributed by Stryker Lebinger GmbH & Co.
Freiburg, Germany.
The Profyle System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screws techniques, joint fusion, corrective osteotomies, and the treatment of fractures
Code Information S T-Bone Plate, Product number: 57-05260; Lot Code G4M 00F1576; M T-Compression Plate, Product number 57-10260; Lot Code G4N00F1584 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall		 A package labeled as a S T-Bone Plate, Catalog Number 57-05260, Lot Code G4M00F1576, may actually contain a M T-Compression Plate, Catalog Number 57-10250, Lot Code G4N00F1584 and vice versa.
FDA Determined
Cause 2		 Process design
Action Stryker Orthopedics sent an Important Market Withdrawal letter dated May 26, 2006, by Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory, including their hospital consignment location, to identify the product. If the affected product remained in its original packaging, customers were instructed to retrieve all of the affected product lots and return it to their branch or agency warehouse for reconcillation. Reconcile all product on the attached Product Accountability Form and fax a copy of the form to 201-831-6069 within 5 days of receipt of the notice. Customers were asked to return the affected product via Inter-Org Transfer and ship to Product Surveillance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, USA 07430-2104. Customers were also instructed to contact their Stryker Orthopaedics Customer Service representataive to re-order the product that they were returning. For questions regarding this recall call (201) 831-5825.
Quantity in Commerce 21
Distribution Nationwide Distribution
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 = HRS and Original Applicant = HOWMEDICA OSTEONICS CORP.
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