Device recall: A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti…
Class II FDA enforcement event 85642. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Acuity Surgical Devices, LLC started this device recall on 7 Jan 2019. The firm address in the FDA record is in Irving, TX. FDA put the recall in Class II. FDA event 85642 has 2 product records. The first FDA enforcement report date is 17 Jun 2020. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
Recalling firm
Acuity Surgical Devices, LLC, Irving, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2354-2020 | 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… | A total of 27 lots producing 178 units | Class II | Ongoing | 17 Jun 2020 |
| Z-2355-2020 | 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… | A total of 27 lots producing 178 units | Class II | Ongoing | 17 Jun 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-2354-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 85642. https://recallregister.com/fda/ii/85642/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
- What quantity of product is in FDA event 85642?
- The event has 2 product records. The first record gives this quantity:
A total of 27 lots producing 178 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.