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PDT, Inc.

PDT, INC. · Model R926 PDT Diamond Tissue Grafting Kit · UDI-DI 00813677024909

HXK EJY EKB EAX FSM EMS EIX EJB EMJ EMO EGN GDZ

510(k) clearances

114

Adverse events

Recalls

242

Facilities

Description

Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R077) Younger-Good 7-8 (R226) 23 Explorer-UNC15 Probe (R245) Cone Socket Mirror Handle (R442) Periosteal Elevator (2mm) (R443) Periosteal Elevator (3mm) (R444) End Cutting Intrasulcular Knife (R445) Modified Orban Knife (T050) #5 Mirror (15/16") (T085) Diamond Coated Corn Suture Pliers (T087) Diamond Coated Micro Straight Pliers (17.5cm) (T088) Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) (T705) Adjustable Scalpel Handle (T815) Goldman-Fox Curved Black Scissors (12.5cm)

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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Data 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.