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PDT, Inc.

PDT, INC. · Model R927 PDT Tissue Grafting Kit · UDI-DI 00813677024916

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

510(k) clearances

Adverse events

Recalls

371

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") (T084) Corn Suture Pliers (T086) Micro Straight Pliers (17.5cm) (T088) Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) (T705) Adjustable Scalpel Handle (T813) Goldman-Fox Curved Scissors (12.5cm)

Recalls

Date	Firm	Reason
2021-03-23	Sunstar Americas, Inc.	Product may be contaminated with Burkholderia contaminans.

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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.