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Helical Blade Inserter for Trochanteric Fixation… recallZ-2091-2015 · Synthes (USA) Products LLC · initiated Jun 10, 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 (USA) Products LLC 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 height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

FDA root cause category: Process control

What the company is doing

A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.

Recall details

Recall number
Z-2091-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 10, 2015
Posted by the FDA
Jul 16, 2015
Recalling firm
Synthes (USA) Products LLC
Quantity
32
Product code
HSB
FDA submissions
K131548
Distribution
Nationwide Distribution.

Product description

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

Code information (models, lots, serial numbers)

Part Number Lot Numbers 03.037.024 T102759

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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