Z-1745-2013Class II

Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector...

Name: Z-1745-2013 Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector...
Creator: Synthes USA HQ, Inc.
Published: 2013-05-31
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-05-31 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone... on 2013-05-31. FDA classified it as Class II and gives the reason as "Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and...". 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-1745-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-31
Posted: 2013-07-17
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
Product code: DZL Screw, Fixation, Intraosseous
Reason for recall: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent a Urgent Notice: Medical Device Removal letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however, there is a remote potential that additional intervention would be required due to a non-functioning clamp. Synthes requested the product to be removed from inventory and returned to Synthes by calling 1-800-479-6329 to obtain a Return Authorization Number. Direct Accounts were asked to complete and return the Verification Section at the end of the letter indicating the quantity of affected product was found. Negative responses were also requested. If you have any questions please call (610) 719-5450.
Quantity in commerce: 121
Distribution: US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
Product codes and lots: Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1745-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1745-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-17

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)