Z-2355-2020Class II

A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7...

Name: Z-2355-2020 A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7...
Creator: Acuity Surgical Devices, LLC
Published: 2019-01-07
License: https://open.fda.gov/license/

Acuity Surgical Devices, LLC / initiated 2019-01-07 / Open, Classified / root cause: manufacturing process

FDA source

Acuity Surgical Devices, LLC began a recall of 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... on 2019-01-07. FDA classified it as Class II and gives the reason as "Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2355-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-07
Posted: 2020-06-11
Recalling firm: Acuity Surgical Devices, LLC
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.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2355-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2354-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-11
Z-2355-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-11

Product code OVD

K133827Class IIA-Link ZOsteo Vasive, LLC / cleared 2014-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)