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U.S. Department of Health and Human Services

Class 2 Device Recall INTEGRA Spinal Tray

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  Class 2 Device Recall INTEGRA Spinal Tray see related information
Date Initiated by Firm August 04, 2016
Create Date August 29, 2016
Recall Status1 Terminated 3 on December 19, 2016
Recall Number Z-2684-2016
Recall Event ID 74867
510(K)Number K943319  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Code Information The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556;
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 W 2400 S Ste 1050
Salt Lake City UT 84119-1135
For Additional Information Contact Dr. Patricia W. Kihn
801-886-9505
Manufacturer Reason
for Recall		 Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.
FDA Determined
Cause 2		 Other
Action Integra sent an Urgent Medical Device letter dated August 4, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return unused, affected product. Confirmation of the recall notification delivery via delivery verifiable email; Return of Recall Acknowledgement form; Return & disposition of unused, affected product, if the customer in their response indicates they have affected devices. Any products returned to Integra as a result of the recall will be stored in a segregated, labeled area. Recalled products that are returned will be dispositioned as scrap and destroyed. Any Lidocaine returned with the products will be dispositioned as directed in the Hospira Inc. Drug Recall Notification. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210. For further questions, please call (801) 886-9505.
Quantity in Commerce 200 packages (20 cases)
Distribution US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee.
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 = CAZ and Original Applicant = SPINAL SPECIALTIES, INC.
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