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DORO® Blade

Black Forest Medical GmbH · Model 3116-101 · UDI-DI 04250435503034

HAO Prescription
10
510(k) clearances
351
Adverse events
2
Recalls
212
Facilities

Description

DORO® Blade Set 102 mm, Black Coated, 5 pcs consisting of: 3116-111 3116-121 3116-131 3116-141 3116-151

Recalls

DateFirmReason
2011-04-04Zimmer Inc.A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdrive
2010-07-02Integra LifeSciences CorpCertain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.

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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.