Z-0388-2014Class II

Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation...

Name: Z-0388-2014 Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation...
Creator: Synthes USA HQ, Inc.
Published: 2013-07-31
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-31 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of... on 2013-07-31. FDA classified it as Class II and gives the reason as "All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension". 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-0388-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-11-25
Terminated: 2015-06-01
Recalling firm: Synthes GmbH
Product: Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent an Urgent: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. "Please remove this product from your inventory and return it to Synthes. A replacement product will be sent to you when available. If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form (page 3 of this letter) with the product to: " Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. "Return the document to Synthes by: Fax: 877-272-3517 "Email: [email protected] If you have any questions, please call 610-719-5450 or email [email protected] We apologize for any inconvenience this may cause and thank you in advance for your attention and cooperation.
Quantity in commerce: 369
Distribution: Nationwide Distribution.
Product codes and lots: all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0388-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0388-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-25

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)