Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Innovasis Excella II Standard

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Innovasis Excella II Standardsee related information
Date Initiated by FirmJuly 07, 2014
Date PostedJuly 16, 2014
Recall Status1 Terminated 3 on August 11, 2014
Recall NumberZ-2067-2014
Recall Event ID 68781
510(K)NumberK102248 K140238 
Product Classification spinal fixation - Product Code NKB
ProductExcella 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
FEI Number 3004719693
Recalling Firm/
Manufacturer		 Innovasis, Inc
614 E 3900 S
Salt Lake City UT 84107-1902
For Additional Information ContactMarshall 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
ActionDistributors 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 Commerce32
DistributionDistribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
-
-