Z-1689-2011

DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is...

Name: Z-1689-2011 DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is...
Creator: Depuy Orthopaedics, Inc.
Published: 2011-01-27
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2011-01-27 / Terminated / root cause: manufacturing process

FDA source

Depuy Orthopaedics, Inc. began a recall of DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the... on 2011-01-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1689-2011
Status: Terminated
Initiated: 2011-01-27
Posted: 2011-03-17
Terminated: 2013-04-23
Recalling firm: Depuy Orthopaedics Inc.
Product: DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.
Product code: JDK Prosthesis, Hip, Cement Restrictor
Reason for recall: 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 tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 40
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 codes and lots: Product Code 546014000, Lot s ET5EA4 and ET5EB4, Size 3.

Product code JDK

K800894Class IIDupuy Cement Restrictor Trials & Instr.Depuy, Inc. / cleared 1980-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)