Product Safety Recalls

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RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Recall 87251

Description: CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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).

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Recall 87251 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1222-2021
Event ID87251
Event DescriptionCervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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 TypeDevices
DistributionUS Nationwide distribution.
Recall ReasonLocking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Device Classification20210317
Device Code InfoBatch Number: 333019 333020 338839 341491 346885 351526 354405 359842 359843 363443 364532 369362 370404 377837 379929 385416
Center Classification Date20210311
Recall Initiation Date20210115
Recalling FirmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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