RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): Medical Device Recall in 2021 - (Recall #: Z-1221-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - 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).

Product Classification:

Class II

Date Initiated: January 15, 2021

Date Posted: March 17, 2021

Recall Number: Z-1221-2021

Event ID: 87251

Reason for Recall:

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

Status: Ongoing

Product Quantity:

Code Information:

Batch Number: 333017 333018 338838 346883 346884 351525 354404 358458 359841 364531 369361 370402 377835 377836 379927

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated