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U.S. Department of Health and Human Services

Class 2 Device Recall Excella II Rod

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  Class 2 Device Recall Excella II Rod see related information
Date Initiated by Firm December 07, 2015
Date Posted January 19, 2016
Recall Status1 Terminated 3 on April 07, 2016
Recall Number Z-0662-2016
Recall Event ID 72878
510(K)Number K102248  K140238  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502
Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

Intended for use in the non-cervical area of the spine.
Code Information Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Recalling Firm/
Manufacturer		 Innovasis, Inc
614 E 3900 S
Salt Lake City UT 84107-1902
For Additional Information Contact Mr. Marshall McCarty
801-261-2236
Manufacturer Reason
for Recall		 Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
FDA Determined
Cause 2		 Labeling mix-ups
Action Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt.
Quantity in Commerce 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Distribution Distributed in US -- CA; KS; OH; & 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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = INNOVASIS, INC.
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