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COSY

SIGNUS Medizintechnik GmbH · Model Occiput, drill guide sleeve variable · UDI-DI 04047844111352

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510(k) clearances

Adverse events

Recalls

Facilities

Description

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

Recalls

Date	Firm	Reason
2015-05-27	Musculoskeletal Transplant Foundation, Inc.	Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm

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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.