A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product recall
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…
Why was A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product recalled?
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Acuity Surgical Devices, LLC
- Quantity
- 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
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)