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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 Device see related information
Date Initiated by Firm January 07, 2019
Create Date June 11, 2020
Recall Status1 Open3, Classified
Recall Number Z-2354-2020
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 Plate-Cage 32x21x15 7
A Link Z Ti Unitary Plate-Cage 32x21x15 12
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Z Ti Unitary Plate-Cage 32x21x15 20
A Link Z Ti Unitary Plate-Cage 32x21x15 20
A Link Z Ti Unitary Plate-Cage 32x21x15 20
A Link Z Ti Unitary Plate-Cage 32x21x17 12
A Link Z Ti Unitary Plate-Cage 32x21x17 16
A Link Z Ti Unitary Plate-Cage 32x21x17 20
A Link Z Ti Unitary Plate-Cage 32x21x19 20
A Link Z Ti Unitary Plate-Cage 32x24x15 7
A Link Z Ti Unitary Plate-Cage 32x24x15 16
A Link Z Ti Unitary Plate-Cage 36x26x15 12
A Link Z Ti Unitary Plate-Cage 36x26x15 12
A Link Z Ti Unitary Plate-Cage 36x26x15 16
A Link Z Ti Unitary Plate-Cage 36x26x15 16
A Link Z Ti Unitary Plate-Cage 36x26x15 16
A Link Z Ti Unitary Plate-Cage 36x26x15 16
A Link Z Ti Unitary Plate-Cage 36x26x15 20
A Link Z Ti Unitary Plate-Cage 36x26x15 20
A Link Z Ti Unitary Plate-Cage 36x26x15 20
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 14-32211507 A Link Z Ti Unitary Plate-Cage 32x21x15 7 1000638 14-32211512 A Link Z Ti Unitary Plate-Cage 32x21x15 12 1000259 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000260 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000325 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000529 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000261 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000469 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000556 14-32211712 A Link Z Ti Unitary Plate-Cage 32x21x17 12 1000262 14-32211716 A Link Z Ti Unitary Plate-Cage 32x21x17 16 1000640 14-32211720 A Link Z Ti Unitary Plate-Cage 32x21x17 20 1000641 14-32211920 A Link Z Ti Unitary Plate-Cage 32x21x19 20 1000530 14-32241507 A Link Z Ti Unitary Plate-Cage 32x24x15 7 1000211 14-32241516 A Link Z Ti Unitary Plate-Cage 32x24x15 16 1000536 14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12 1000282 14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12 1000583 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000232 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000383 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000479 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000652 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000233 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000360 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000584 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
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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