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U.S. Department of Health and Human Services

Class 2 Device Recall ZeusP Lumbar Interbody Device

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 Class 2 Device Recall ZeusP Lumbar Interbody Devicesee related information
Date Initiated by FirmNovember 22, 2016
Date PostedDecember 20, 2016
Recall Status1 Terminated 3 on June 05, 2017
Recall NumberZ-0827-2017
Recall Event ID 75855
510(K)NumberK151322 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductZeus-P Lumbar Interbody Device
Code Information Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946 
FEI Number 3007970248
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		Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
FDA Determined
Cause 2		Error in labeling
ActionAmendia Inc. sent an Urgent - Medical Device Recall letter dated November 22, 2016, to all affected customers. 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 Commerce25 units
DistributionUS Distribution to the states of : GA. MI, OK, SC, TX, VA
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 = MAX
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