Recall Z-1821-2013— Synthes USA HQ, Inc.

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2012-10-12, terminated 2015-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo. Reason: A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action..

Recalling firm

Synthes USA HQ, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-10-12

Terminated

2015-06-11

Firm location

West Chester, PA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.