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MSI Precision Specialty Instruments

Med Saver, Inc. · Model DB68-445 · UDI-DI 00194613036614

HTW Prescription
10
510(k) clearances
17,754
Adverse events (5 deaths)
114
Recalls
557
Facilities

Description

Twist Drill Bit, Round Drill Chuck End, 4.5mm Diameter, 34mm Flute, Overall Length 5" (127mm)

Recalls

DateFirmReason
2026-02-11Waldemar Link GmbH & Co. KG (Mfg Site)The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de
2026-02-11Waldemar Link GmbH & Co. KG (Mfg Site)The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps de
2024-01-29Waldemar Link GmbH & Co. KG (Mfg Site)The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of
2024-01-29Waldemar Link GmbH & Co. KG (Mfg Site)The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of
2021-09-01Flower Orthopedics CorporationDrill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01Flower Orthopedics CorporationDrill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01Flower Orthopedics CorporationDrill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-09-01Flower Orthopedics CorporationDrill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
2021-07-30Paragon 28, Inc.A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
2021-02-24Arthrex, Inc.The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

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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.