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PYRAMESH® Implant System
MEDTRONIC SOFAMOR DANEK, INC. · Model 9052830 · UDI-DI 00763000855888
2
510(k) clearances
198
Adverse events (5 deaths)
1
Recalls
26
Facilities
Description
MESH 9052830 PYRAMESH IMP 22MMX28MMX30MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-10-07 | Synthes (USA) Products LLC | The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate. |
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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.
