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INTEGRA®
PMT CORPORATION · Model 3616ES-14-ST · UDI-DI 00650551004585
LCJ
Prescription
1
510(k) clearances
5,147
Adverse events (4 deaths)
21
Recalls
22
Facilities
Description
TISSUE EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS, 11.5X10CM, 250CC FILL VOLUME, 4.5CM PROJECTION
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-18 | Mentor Texas, LP. | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| 2026-02-02 | B Braun Medical Inc | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. |
| 2026-02-02 | B Braun Medical Inc | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. |
| 2026-02-02 | B Braun Medical Inc | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. |
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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.