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Titanium End Cap With T40 Stardrive Recess, 0mm Extension… recallZ-2051-2015 · Synthes, Inc. · initiated Jun 3, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-2051-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 3, 2015
Posted by the FDA
Jul 8, 2015
Recalling firm
Synthes, Inc.
Quantity
3
Product code
JDS
FDA submissions
K040762
Distribution
US Distribution to states of: MO and SC.

Product description

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.

Code information (models, lots, serial numbers)

Part # 04.004.000, lot # 7950994

Other devices under the same FDA submission

71 devices cleared under K040762 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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