Z-2051-2015Class II

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail...

Name: Z-2051-2015 TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail...
Creator: Synthes, Inc.
Published: 2015-06-03
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2015-06-03 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the... on 2015-06-03. FDA classified it as Class II and gives the reason as "A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection". 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-2051-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-07-08
Terminated: 2015-09-15
Recalling firm: Synthes GmbH
Product: TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Product code: JDS Nail, Fixation, Bone
Reason for recall: A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Depuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" notification letter, dated June 3, 2015, to direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from your stock; 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 (RA)Complete and Return the Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section even if you do not have any product to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: [email protected] Number. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 3
Distribution: US Distribution to states of: MO and SC.
Product codes and lots: Part # 04.004.000, lot # 7950994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2051-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-08

Product code JDS

K040762Class IISynthes (USA) Tibial Nail System ExSynthes (Usa) / cleared 2004-04-12

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)