Home › Highridge Medical, LLC › Timberline Lateral Fusion System
Timberline Lateral Fusion System
Highridge Medical, LLC · Model 8732-6108 · UDI-DI 03662663267243
7
510(k) clearances
307
Adverse events (5 deaths)
6
Recalls
273
Facilities
Description
DISSECTOR BLUNT BAYONETED
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
| 2011-12-09 | Progressive Medical Inc | Some of the sterile packages had broken seals. |
| 2011-10-28 | Progressive Medical Inc | The tip of the product could come loose or unravel. |
| 2010-03-01 | He, Inc | Sterile product packaging contains weak seals, which may result in compromised product sterility. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
| 2007-11-06 | Ethicon Endo-Surgery Inc | Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.