PDT, Inc.
PDT, INC. · Model R911 PDT Mission Surgical Extraction Kit · UDI-DI 00813677024817
10
510(k) clearances
2,357
Adverse events (2 deaths)
36
Recalls
875
Facilities
Description
Kit Includes: T015E-U FlipTop™ Cassette 'E' - Utility T120 Luxating instrument-2 T121 Luxating instrument-3 T108 Root elevator CRYER 39 T109 Root elevator CRYER 40 T790 Extracting forceps 150 extra grip T792 Extracting forceps 151 extra grip T794 Extracting forceps 23 Cowhorn T714 TC Needle Holder CRILE WOOD T820 Scissors La-Grange 11.5
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2024-06-11 | Medical Action Industries, Inc. 306 | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foa |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile |
| 2023-02-23 | Aesculap Implant Systems LLC | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2021-11-24 | Howmedica Osteonics Corp. | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: |
| 2019-06-10 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation. |
| 2019-06-10 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation. |
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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.