Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1821-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 12, 2012

Date Posted: August 7, 2013

Recall Number: Z-1821-2013

Event ID: 65668

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2

Code Information:

Part Number SD389.477, Lot Number 6913900

Distribution Pattern:

US distribution: PA only. .

Voluntary or Mandated:

Voluntary: Firm initiated