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Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm recallZ-1352-2015 · Synthes, Inc. · initiated Feb 24, 2015

Class II Terminated All recalls posted in March 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

The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

FDA root cause category: Component design/selection

What the company is doing

DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.

Recall details

Recall number
Z-1352-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 24, 2015
Posted by the FDA
Mar 30, 2015
Recalling firm
Synthes, Inc.
Quantity
131
Product code
HSB
FDA submissions
K131548
Distribution
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA

Product description

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Code information (models, lots, serial numbers)

Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026,  9124016, 9124027, 8918563

Other devices under the same FDA submission

172 devices cleared under K131548 — 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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