Z-1228-2021Class II

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 -

Name: Z-1228-2021 CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 -
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2021-01-15
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2021-01-15 / Open, Classified

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for... on 2021-01-15. FDA classified it as Class II and gives the reason as "Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1228-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-15
Posted: 2021-03-11
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - 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 code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
FDA root cause: Under Investigation by firm
Action: Pioneer Surgical Technology, Inc. (DBA RTI Surgical) initiated email notification on 15 January 2021 via the Distributor. End Users notified via Distributor by First Class Mail. Letter states reason for recall, health risk and action to take: Remove from all user sites and inventory locations the CervAlign Anterior Cervical Plates listed in the attached distribution list. Kindly return CervAlign Anterior Cervical Plates RTI Surgical along with the appropriate forms. RTI Surgical is working on corrective actions to prevent these events from reoccurring. We do not know at this time how long this will take to apply these corrective actions, but as soon as we do, we will notify you. If you have any questions or concerns, please contact me at your earliest convenience. RTI Surgical apologizes for any inconvenience this caused Surgalign. Thank you for your cooperation. Contact: Director of Quality Pioneer Surgical (d.b.a. RTI Surgical), 375 River Park Circle, Marquette, MI 49855 U.S.A. (www.rtix.com) P: 763-238-2034 E: [email protected]
Distribution: US Nationwide distribution.
Product codes and lots: Batch Number: 342452 348027 351950 357125 364537 380155 380156 385417

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1228-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1204-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1205-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1206-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1207-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1208-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1209-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1210-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1211-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1212-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1213-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1214-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1215-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1216-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1217-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1218-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1219-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1220-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1221-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1222-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1223-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1224-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1225-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1226-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1227-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1228-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1229-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1230-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1231-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1232-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1233-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1234-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1235-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1236-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1237-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1238-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1239-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1240-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1241-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1242-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1243-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1244-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-17	2021-03-11

Product code KWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)