Recall Z-1218-2021— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Name: FDA recall Z-1218-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Class II · Ongoing

Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2021-01-15. It names one FDA 510(k) clearance: K183060. Product: CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).. Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision.

Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Classification: Class II
Status: Ongoing
Initiated: 2021-01-15
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K183060 — CervAlign Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)·cleared 2019-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Reason for recall

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Data sourced from openFDA. This site is unofficial and independent of the FDA.