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Synthes GmbH · Model 05.001.185 · UDI-DI 10886982129581
10
510(k) clearances
22,777
Adverse events (3 deaths)
258
Recalls
140
Facilities
Description
IRRIGATION NOZZLE FOR EPD AND APD FOR USE WITH 05.001.183
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| 2026-04-30 | SURGIFY MEDICAL OY | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
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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.