Z-0942-2013Class II

Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and...

Name: Z-0942-2013 Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and...
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 Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones on 2013-01-11. FDA classified it as Class II and gives the reason as "There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized". 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-0942-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-03-12
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Product code: JEY Plate, Bone
Reason for recall: There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to all consignees. The letter identified the affected product and the problem. Also, the firm requested consignees to examine their inventory for products(s) with the specified part number, remove them from use, and return them to Synthes. Customers were to follow the instructions provided on what to do if they have or do not have any identified affected product. Questions should be directed to 610-719-5450 or [email protected].
Quantity in commerce: 596
Distribution: Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-11

Product code JEY

K010499Class IISynthes (USA) Midface DistractorSynthes (Usa) / cleared 2001-05-03

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)