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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

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  Class 2 Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK see related information
Date Initiated by Firm January 10, 2012
Date Posted February 13, 2012
Recall Status1 Terminated 3 on November 05, 2012
Recall Number Z-1003-2012
Recall Event ID 61038
Product Classification Tray surgical - Product Code LRP
Product Custom surgical kits:
DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849

DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849

DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849

surgical kits
Code Information REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676 
Recalling Firm/
Manufacturer		 DeRoyal Processing Center
1703 Highway 33 S
New Tazewell TN 37825-5043
For Additional Information Contact Tracy Edmundson
865-362-2334 Ext. 1325
Manufacturer Reason
for Recall		 The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.
Quantity in Commerce 214 units
Distribution (USA) including Indiana
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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