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U.S. Department of Health and Human Services

Class 2 Device Recall Innovasis Excella II Standard

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  Class 2 Device Recall Innovasis Excella II Standard see related information
Date Initiated by Firm July 07, 2014
Date Posted July 16, 2014
Recall Status1 Terminated 3 on August 11, 2014
Recall Number Z-2067-2014
Recall Event ID 68781
510(K)Number K102248  K140238  
Product Classification spinal fixation - Product Code NKB
Product Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Code Information E2S47525 Lot 1301 and E2S47535 Lot 1301
Recalling Firm/
Manufacturer		 Innovasis, Inc
614 E 3900 S
Salt Lake City UT 84107-1902
For Additional Information Contact Marshall C. McCarty
801-261-2236
Manufacturer Reason
for Recall		 Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
FDA Determined
Cause 2		 Process control
Action Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.
Quantity in Commerce 32
Distribution Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
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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