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TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM
BIOMET SPINE LLC · Model 8615-5016 · UDI-DI 00880304828261
0
510(k) clearances
220
Adverse events (8 deaths)
3
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-06 | VANTIVE US HEALTHCARE LLC | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| 2014-07-18 | Gambro Renal Products, Incorporated | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| 2014-07-18 | Gambro Renal Products, Incorporated | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
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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.