Z-1821-2013Class II

Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods...

Name: Z-1821-2013 Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods...
Creator: Synthes USA HQ, Inc.
Published: 2012-10-12
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-10-12 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of 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... on 2012-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1821-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-12
Posted: 2013-07-29
Terminated: 2015-06-11
Recalling firm: Synthes GmbH
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
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA root cause: 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. .
Product codes and lots: Part Number SD389.477, Lot Number 6913900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1821-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)