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MID CENTRAL MEDICAL CORP. · Model MCM357 · UDI-DI 10810030861406

KQZ
10
510(k) clearances
42
Adverse events (1 deaths)
9
Recalls
115
Facilities

Description

Finger Trap for suspending digits in traction during surgery. Holds digits securely and evenly with out compromising circulation for the duration of the surgery.Medium

Recalls

DateFirmReason
2021-12-14Smith & Nephew, Inc.Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
2018-06-21Ossur AmericasHalo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2018-06-21Ossur AmericasHalo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2016-03-14Ossur H / FThere is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14Ossur H / FThere is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14Ossur H / FThere is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14Ossur H / FThere is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14Ossur H / FThere is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
2016-03-14Ossur H / FThere is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

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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.