FDA Enforcement Class II Ongoing

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 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x17 12 A Link Z Ti Unitary Plate-Cage 32x21x17 16 A Link Z Ti Unitary Plate-Cage 32x21x17 20 A Link Z Ti Unitary Plate-Cage 32x21x19 20 A Link Z Ti Unitary Plate-Cage 32x24x15 7 A Link Z Ti Unitary Plate-Cage 32x24x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 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.

Recall: Z-2354-2020 · Reported June 17, 2020

Enforcement

Recall Number: Z-2354-2020
Event ID: 85642
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Acuity Surgical Devices, LLC
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Other
Report Date: June 17, 2020
Initiation Date: January 7, 2019
Classification Date: June 11, 2020
Address: 8710 N Royal Ln, N/A, Irving, TX, 75063-2539, United States

Description

Reason

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

Code Info

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

Distribution

US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None

Quantity

A total of 27 lots producing 178 units