Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1217-2021 — CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - 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

U.S. FDA — Device Enforcement · United States · 2021-01-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1217-2021
Date of alert: 2021-01-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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