Reported Jun 17, 2020 · Ongoing
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z…
Acuity Surgical Devices, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acuity Surgical Devices, LLC · 8710 N Royal Ln · Irving, TX · 75063-2539
Is this the product you have?
- A LINK Z INTERVERTEBRAL
- BODY FUSION DEVICE Product DescriptionA 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 Usageis a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion
- Lot codes and dates
- 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
- Amount recalled
- A total of 27 lots producing 178 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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