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DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive… recallZ-1915-2015 · Synthes, Inc. · initiated May 27, 2015

Class II Terminated All recalls posted in June 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

certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).

FDA root cause category: Process control

What the company is doing

DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: Review the information listed in this notification. Forward this notice to anyone in your facility that needs to be informed. Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by: Fax: (888) 912-2182 or Scan/email: [email protected] If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. Maintain a copy of this notice. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.

Recall details

Recall number
Z-1915-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 27, 2015
Posted by the FDA
Jun 26, 2015
Recalling firm
Synthes, Inc.
Quantity
276
Product code
HSB
FDA submissions
K040336
Distribution
Nationwide Distribution.

Product description

DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.

Code information (models, lots, serial numbers)

Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036

Other devices under the same FDA submission

37 devices cleared under K040336 — 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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