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U.S. Department of Health and Human Services

Class 2 Device Recall A Link Z Intervertebral Body Fusion Device

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 Class 2 Device Recall A Link Z Intervertebral Body Fusion Devicesee related information
Date Initiated by FirmJanuary 07, 2019
Create DateJune 11, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2355-2020
Recall Event ID 85642
510(K)NumberK133827 
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
ProductA LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.
Code Information Product Product Description Lot Number Number 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577 
FEI Number 3010866843
Recalling Firm/
Manufacturer		 Acuity Surgical Devices, LLC
8710 N Royal Ln
Irving TX 75063-2539
For Additional Information ContactCharlie Forton
817-228-4890
Manufacturer Reason
for Recall		Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
FDA Determined
Cause 2		Process control
ActionOn 12/14/2018, the firm notified its supplier via email requesting to visually review its inventory which determined that some screw holes were oval shaped. On 7/23/2019, all inventory was quarantined as part of the removal and was scrapped from inventory. Due to the low risk to patients and low probability, the firm ownly initially begin removal of product from internal locations (main warehouse) for the purpose of inspection and if necessary, repair or destruction. Removal Summary No additional customer or distributor communication took place during the removal.
Quantity in CommerceA total of 27 lots producing 178 units
DistributionUS Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OVD
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