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i-FACTOR Peptide Enhanced Bone Graft
Cerapedics Inc. · Model 700-010 · UDI-DI 00850001680004
NOX
Prescription
0
510(k) clearances
178
Adverse events
4
Recalls
5
Facilities
Description
i-FACTOR Putty, 1.0cc Syringe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-29 | Cerapedics, Inc. | Incorrect expiration date |
| 2022-04-14 | Cerapedics, Inc. | Patient chart label contains incorrect Part Number and volume amount. |
| 2021-07-23 | BioMimetic Therapeutics, LLC | The kit contains the wrong vial tray in the package. |
| 2010-08-26 | Theken Spine Llc | The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes. |
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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.