Z-2583-2010

SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant...

Name: Z-2583-2010 SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant...
Creator: Synthes USA (HQ), Inc.
Published: 2010-07-23
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2010-07-23 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA (HQ), Inc. began a recall of SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the... on 2010-07-23. The reason FDA records is "A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2583-2010
Status: Terminated
Initiated: 2010-07-23
Posted: 2015-06-26
Terminated: 2014-12-18
Recalling firm: Synthes GmbH
Product: SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: [email protected]. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.
Distribution: Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.
Product codes and lots: Catolog Number: 03.802.039 - all lot numbers

Product code MQP

K053508Class IISynfix-LrSynthes Spine Co.Lp / cleared 2006-02-13

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)