Z-0539-2010

Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics...

Name: Z-0539-2010 Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-01-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-01-24 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430... on 2007-01-24. The reason FDA records is "The tips of the forceps were larger than the positioning holes located on the trials and the implant liners". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0539-2010
Status: Terminated
Initiated: 2007-01-24
Posted: 2009-12-16
Terminated: 2009-12-21
Recalling firm: Howmedica Osteonics Corp
Product: Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430; Authorized representative in Europe: Stryker France, Cedex. France The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
Product code: HTD Forceps
Reason for recall: The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.
FDA root cause: Pending
Action: Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.
Quantity in commerce: 351 units
Distribution: Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.
Product codes and lots: All lots beginning with V1 (XXX).

Product code HTD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)