Z-0903-2013Class II

Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening

Name: Z-0903-2013 Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

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

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening on 2013-01-11. FDA classified it as Class II and gives the reason as "It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0903-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-03-01
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Product code: DZL Screw, Fixation, Intraosseous
Reason for recall: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
Quantity in commerce: 2
Distribution: Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
Product codes and lots: Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0903-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0903-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-01
Z-0904-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-01
Z-0905-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-01

Product code DZL

K010690Class IISynthes Titanium Multi-Vector DistractorSynthes (Usa) / cleared 2001-05-18

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)