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Steri-Endo Guard Plum

ZIRC DENTAL PRODUCTS, INC. · Model 50Z452E · UDI-DI 00840161301352

FSM Prescription

510(k) clearances

2,231

Adverse events (2 deaths)

Recalls

874

Facilities

Description

"Holds most lengths for staging, cleaning, sterilizing files and reamers Millimeter gauge measures files and positions rubber stopper Right or left hand use Single foam insert cleans and holds files Sterilization counter on locking bar tracks the number of times instruments have been sterilized Organizes up to 11 Engine and 5 Hand files Dimensions: 5-3/8"" x 3/8"" x 2-3/16"" Autoclavable up to 136°C/275°F Washer-disinfect"

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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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.