—#97713

Product

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

FDA product code: JDK — Prosthesis, Hip, Cement Restrictor
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K800894
Affected lot / code info: Product Code 546018000, Lot sET5EV4 and ET5EB4, Size 5.

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-01-27
Posted by FDA: 2011-03-17
Terminated: 2013-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97713. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.