Z-1057-2014Class II

Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their...

Name: Z-1057-2014 Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their...
Creator: Synthes, Inc.
Published: 2014-01-07
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-01-07 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving... on 2014-01-07. FDA classified it as Class II and gives the reason as "The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1057-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-07
Posted: 2014-02-20
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Synthes sent an Urgent Notice - Medical Device Recall Letter dated January 7 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken: Our records indicate that your facility has the product(s) subject to this Recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call DePuy 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 indication 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 documents to DePuy Synthes by: " Fax: 877-271-1473 or " Scan/email: [email protected] If you have any questions,please call 610-719-5450. Thank you for your attention to this issue.
Quantity in commerce: 143
Distribution: USA (nationwide) Distribution.
Product codes and lots: Part No. 03.010.523, Lot Nos. 8279162 & 8429004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1057-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1057-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

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)