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DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size… recallZ-1690-2011 · Depuy Orthopaedics, Inc. · initiated Jan 27, 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 became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

FDA root cause category: Employee error

What the company is doing

DePuy Orthopaedics sent an URGENT INFORMATION RECALL NOTICE dated January 27, 2011, to DePuy Area Directors, FMDs, Distributors, and Office Managers. The notice identified the product, the problem, and the action to be taken. All territories were required to ensure that all recalled products that remain in customer accounts and field inventory are returned immediately to Warsaw to the attention of Returns. Hospitals that purchased and potentially implanted the now recalled product should be provided appropriate notification of the recall and should complete and return a signed Reconciliation Form(s) within seven business days. If the hospitals have any inventory on hand that is subject to the recall, distributors should remove it or help the hospitals return it for credit. All Reconciliation Forms should be faxed to 574-372-7567. For questions regarding this recall call 574-372-7333.

Recall details

Recall number
Z-1690-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 27, 2011
Posted by the FDA
Mar 17, 2011
Recalling firm
Depuy Orthopaedics, Inc.
Quantity
20
Product code
JDK
FDA submissions
K800894
Distribution
Nationwide distribution including the states of MA, PA, FL, LA, MN, WA, WI, CO, GA, NY, NC and SC and the countries of Canada, Colombia, Ireland and Argentina.

Product description

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis

Code information (models, lots, serial numbers)

Product Code 546018000, Lot sET5EV4 and ET5EB4, Size 5.

Other devices under the same FDA submission

1 device cleared under K800894 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 57900).

Sources and updates

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