Z-0405-2014Class II

Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered...

Name: Z-0405-2014 Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered...
Creator: Synthes USA HQ, Inc.
Published: 2013-10-08
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-10-08 / Terminated

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to... on 2013-10-08. FDA classified it as Class II and gives the reason as "Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0405-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-08
Posted: 2013-11-27
Terminated: 2016-08-26
Recalling firm: Synthes GmbH
Product: Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
FDA root cause: Unknown/Undetermined by firm
Action: Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 548
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada .
Product codes and lots: all lots of part no. 03.802.039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0405-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0405-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)