Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension

FDA device recall Z-0286-2013 · posted 2012-11-13 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.

Action taken

Stryker Orthopaedics sent an Urgent Product Recall letter dated July 16, 2012 via Fed Ex with return receipt to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were instructed to fax back the attached Product Recall Acknowledgement Form to 201-821-6069. For questions call 201-972-2100.

Root cause

Device Design

Status

Terminated

Product code

JDI

Quantity affected

301 units

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2012-07-16

Date posted

2012-11-13

Date terminated

2015-09-09

Location

Mahwah, NJ