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U.S. Department of Health and Human Services

Class 2 Device Recall Synapse SD Drill Guide

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 Class 2 Recall
Synapse SD Drill Guide
see related information
Date Posted July 29, 2013
Recall Status1 Open
Recall Number Z-1821-2013
Recall Event ID 65668
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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
Code Information Part Number SD389.477, Lot Number 6913900
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Manufacturer 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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action 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.
Quantity in Commerce 2
Distribution US distribution: PA only. .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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