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Timberline Lateral Fusion System

Highridge Medical, LLC · Model 8738-5319 · UDI-DI 03662663278928

FZT
10
510(k) clearances
607
Adverse events
6
Recalls
255
Facilities

Description

SOLID WEB ROTATING DISC CUTTER 19MM

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2010-06-04Maquet CardiovascularPouch integrity may be compromised, resulting in loss of sterility.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
2008-04-24Ethicon Endo-Surgery IncThe firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

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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.