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MCBio Supertack Tack 3mm - N.5

MC BIO SRL · Model 9514010-5 · UDI-DI 08056992093010

DZL Prescription

510(k) clearances

1,522

Adverse events

Recalls

Facilities

Description

The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

Recalls

Date	Firm	Reason
2016-02-23	Synthes (USA) Products LLC	Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the th
2016-02-23	Synthes (USA) Products LLC	Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the th
2013-05-31	Synthes USA HQ, Inc.	Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm r
2013-01-11	Synthes USA HQ, Inc.	It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2013-01-11	Synthes USA HQ, Inc.	It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2013-01-11	Synthes USA HQ, Inc.	It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2010-03-17	Biomet Microfixation, Inc.	Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
2009-10-06	Biomet 3i, LLC	Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a materi

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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.