Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corp

FDA device recall Z-0539-2010 · posted 2009-12-16 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

HTD

Quantity affected

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.

Date initiated

2007-01-24

Date posted

2009-12-16

Date terminated

2009-12-21

Location

Mahwah, NJ