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 Optimus Fixed Awl

  • 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 Optimus Fixed Awlsee related information
Date Initiated by FirmNovember 22, 2016
Date PostedDecember 22, 2016
Recall Status1 Terminated 3 on February 28, 2017
Recall NumberZ-0891-2017
Recall Event ID 75856
510(K)NumberK132596 
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
ProductOptimus Fixed Awl
Code Information Part Number 139005 - Lot Number 182-16146
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information ContactBryan Brosseau
404-610-7215
Manufacturer Reason
for Recall		Complaints that the tip of the awl broke after impaction during surgery.
FDA Determined
Cause 2		Device Design
ActionAmendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions, please call (404) 610-7215.
Quantity in Commerce9 devices
DistributionUS Distribution to the states of : FL, GA. IL, MO, TX
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 = OVD
-
-