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PFC Sigma Round Dome Patella 38 MM 3 Peg recallZ-3099-2011 · DePuy Orthopaedics, Inc. · initiated Jun 28, 2011

Terminated All recalls posted in August 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

DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella, but the product enclosed in the package is a P.F.C. SIGMA 35mm 3 peg Oval Dome Patella.

FDA root cause category: Employee error

What the company is doing

The firm, Depuy , sent an email that included a letter entitled "URGENT INFORMATION - RECALL NOTICE" dated June 28, 2011 to DePuy Area customers ( Directors, Distributors, Office Managers, Hospital Representatives, and Doctors). The letter described the product, problem and actions to be taken. The letter also included implications of implanting the recalled device and patient communication information. The customers were instructed to immediately cease further implantation/use or distribution of the product, immediately return any recalled devices in their inventory, notify their customer of the recall and complete, sign and return the Reconciliation Form(s) via fax to DePuy at 574-372-7567 within seven business days. The letter also states that DePuy is not recommending prophylactic revision or additional follow up in the absence of symptoms. Additionally, DePuy recommends that surgeons continue to follow patients as per their standard care. Questions regarding the recall may be directed to the following DePuy representatives--questions about recall information call the Manager of Customer Quality at 574-372-7333; Salesforce questions, call the Group Product Director, 574-372-5046 or Associate Product Director at 574-372-7154 and for Clinical/Surgeon questions, contact DePuy's Scientific Information Office at 1-888-554-2482.

Recall details

Recall number
Z-3099-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 28, 2011
Posted by the FDA
Aug 30, 2011
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
29
Product code
JWH
FDA submissions
K884796
Distribution
Nationwide distribution: CA, MI, NJ and WI.

Product description

PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement.

Code information (models, lots, serial numbers)

Product code 960112, Lot number 3292209

Other devices under the same FDA submission

18 devices cleared under K884796 — 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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