A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product recall
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…
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 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
- 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…
- 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)