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Montage Flowable 8cc
ABYRX, INC. · Model OS-MON-1501FL · UDI-DI 00850391007221
10
510(k) clearances
233
Adverse events
4
Recalls
32
Facilities
Description
Packaging Contains: 1 Montage Flowable Syringe 8cc DI # 00850391007191 1 Montage Flowable Dispenser DI# 00850391007207 3 Montage Flowable Mixing Tips DI # 00850391007214
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2012-07-05 | Synthes USA HQ, Inc. | There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. |
| 2012-01-06 | Synthes, Inc. | Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement. |
| 2008-10-28 | Ethicon, Inc. | A hospital reported to their Ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate |
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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.