Home › Pioneer Surgical Technology, Inc. › Fusion™ Lateral L4-L5 Instrument Set
Fusion™ Lateral L4-L5 Instrument Set
Pioneer Surgical Technology, Inc. · Model 38-A-CURETTE-LG-D · UDI-DI 00846468039899
HTF
Prescription
3
510(k) clearances
116
Adverse events (2 deaths)
2
Recalls
316
Facilities
Description
L4/L5, CUP CURETTE, LARGE, DOWN ANGLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-12 | MEDLINE INDUSTRIES, LP - Northfield | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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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.