Date Initiated by Firm |
January 07, 2019 |
Create Date |
June 11, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2355-2020 |
Recall Event ID |
85642 |
510(K)Number |
K133827
|
Product Classification |
Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
|
Product |
A 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 |
Recalling Firm/ Manufacturer |
Acuity Surgical Devices, LLC 8710 N Royal Ln Irving TX 75063-2539
|
For Additional Information Contact |
Charlie 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 |
Action |
On 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 Commerce |
A total of 27 lots producing 178 units |
Distribution |
US 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 Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = OVD and Original Applicant = OSTEO VASIVE LLC
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