PDT, Inc.
PDT, INC. · Model R925 PDT Bone Grafting Kit · UDI-DI 00813677024893
5
510(k) clearances
115
Adverse events
5
Recalls
242
Facilities
Description
Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R245) Cone Socket Mirror Handle (R432) Slade Blade™ 1 (R433) Slade Blade™ 2 (R434) Slade Blade™ 3 (R435) Slade Blade™ 4 (R436) Slade Blade™ 5 (T050) #5 Mirror (15/16") (T704) Scalpel Handle (T710) Castroviejo Straight Tungsten Carbide Needle Holder (14cm) (T740) Prichard Periosteal Elevator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2023-05-18 | Aesculap Implant Systems LLC | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. |
| 2020-08-17 | ArthroCare Corporation | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless |
| 2019-09-25 | Aesculap Implant Systems LLC | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. |
| 2011-11-08 | DePuy Orthopaedics, Inc. | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the i |
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