—#119839

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number SD389.477, Lot Number 6913900

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

The firm, Synthes USA, sent an email to its customer. The email identified the product, problem and the actions to be taken. The customer was instructed to do the following: do not use this product; do not remove any product from your account or return any product without further instructions. If you have identified that you have the product, please have the product located in an area that ensures it will not be used. Further instructions will be sent out with regards to any action that needs to be taken next. Please call Synthes if you have any questions at 610-719-5364.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: US distribution: PA only. .

Timeline

Recall initiated: 2012-10-12
Posted by FDA: 2013-07-29
Terminated: 2015-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.