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AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile… recallZ-1643-2011 · Depuy Orthopaedics, Inc. · initiated Jan 12, 2011

Terminated All recalls posted in March 2011

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 Depuy Orthopaedics, 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 firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.

FDA root cause category: Other

What the company is doing

On 1/12/2011 DePuy contacted their distributors by telephone and directed the distributors to cancel all pending surgeries and discontinue use of the sets until the investigation is completed. On 1/14/2011 DePuy again contacted all distributors by telephone and directed all distributors to return the instruments to DePuy for inspection as part of the investigation.

Recall details

Recall number
Z-1643-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 12, 2011
Posted by the FDA
Mar 22, 2011
Recalling firm
Depuy Orthopaedics, Inc.
Quantity
296 units
Product code
LXH
FDA submissions
K100238
Distribution
Worldwide Distribution -- US, including the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI; and country of Switzerland.

Product description

AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.

Code information (models, lots, serial numbers)

Lots: E2FGT4, E2FGS4, E28D64, E2FGR4, E2FGP4, and EL8EN4.

Other devices under the same FDA submission

89 devices cleared under K100238 — 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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