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Paeon Posterior Cervical Fixation System

Aegis Spine, Inc. · Model CS02-0101 · UDI-DI 00840273310792

HXB
10
510(k) clearances
605
Adverse events
3
Recalls
371
Facilities

Description

PROBE(ST)

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2014-12-02Zimmer Trabecular Metal Technology, Inc.During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
2013-09-11SpineFrontier, Inc.Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.