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U.S. Department of Health and Human Services

Class 2 Device Recall Codman(R) Collins Radioparent Sternal Blade Nylon

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  Class 2 Device Recall Codman(R) Collins Radioparent Sternal Blade Nylon see related information
Date Initiated by Firm April 10, 2013
Date Posted May 07, 2013
Recall Status1 Terminated 3 on May 12, 2014
Recall Number Z-1267-2013
Recall Event ID 64962
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
Product Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081

sternum retractor
Code Information 244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160
Recalling Firm/
Manufacturer		 Symmetry Medical/SSI
3034 Owen Dr
Antioch TN 37013-2413
For Additional Information Contact Victoria Rogers
615-964-5515
Manufacturer Reason
for Recall		 There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.
FDA Determined
Cause 2		 Under Investigation by firm
Action Symmetry Surgical sent an Urgent Medical Device Recall letter dated April 8, 2013, 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 immediately to determine if they have any of the affected product. If so, customers were instructed to discontinue use of the product immediately and promplty call 800-251-3000 for a return material authorization (RMA) number and to identify if they would like credit or an alternative product. Customers were asked to fill out the attached Recall Response Form and fax the completed form to 615-964-5567. Customers with questions were instructed to call 615-964-5515. For questions regarding this recall call 615-964-5515.
Quantity in Commerce 524 boxes of 10
Distribution Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK
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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