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Posterior Cervical Removal Instruments

Highridge Medical, LLC · Model 7900-3500-044 · UDI-DI 03662663217651

HTC
10
510(k) clearances
412
Adverse events
4
Recalls
243
Facilities

Description

AP211001 ADJUSTABLE PLIERS

Recalls

DateFirmReason
2014-11-14The Anspach Effort, Inc.May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
2014-11-06Synthes (USA) Products LLCThe device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/
2014-08-14The Anspach Effort, Inc.The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
2009-09-03Synthes USA (HQ), Inc.The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.

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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.