Z-0938-2013Class II

Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072...

Name: Z-0938-2013 Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072...
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-01-11 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental... on 2013-01-11. FDA classified it as Class II and gives the reason as "Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0938-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-03-11
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm initiated a recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter, dated January 11, 2013, to all consignees. The letter identified the affected product and the issue, as well as requested that consignees examine their inventory for the product(s) with the identified Part and Lot Numbers, remove them from use, and return them to Synthes. Customers were to follow the steps provided in the letter regarding if they had or did not have any of the identified affected product. Questions were to be directed to 610-719-5450 or [email protected].
Quantity in commerce: 18
Distribution: Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
Product codes and lots: Lot Number 7542279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0938-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-11

Product code MNH

K992739Class IIClick'xSynthes Spine / cleared 2000-02-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)