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Magnetic Bur Block 14-Hole Plum
ZIRC DENTAL PRODUCTS, INC. · Model 50Z403E · UDI-DI 00840161302403
FSM
Prescription
10
510(k) clearances
2,357
Adverse events (2 deaths)
40
Recalls
876
Facilities
Description
"Fits FG, RA and HP bur styles Magnetic base holds burs securely and has non-slip feet for stability Drain holes are on the bottom of the bur blocks to help prevent rusting on the burs Covers are available Dimensions: 2-15/16"" x 1-1/2"" x 1/2"" Autoclavable up to 136°C/275°F Washer-disinfect"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 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. |
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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.