Recalls / —

—#41811

Product

Reliance PF Femoral Stem

FDA product code

MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K970200

Affected lot / code info

Catalog #---Description---- # of lots:  6265-2-000, Reliance PF Hip #0/10MM, 386 lots; 6265-2-001, Reliance PF Hip #1/11MM, 484 lots; 6265-2-002, Reliance PF Hip #2/12MM, 617 lots; 6265-2-003, Reliance PF Hip #3/13MM, 692 lots; 6265-2-004, Reliance PF Hip #4/14MM, 465 lots; 6265-2-005, Reliance PF Hip #5/15MM, 299 lots; 6265-2-006, Reliance PF Hip #6/16MM, 184 lots; 6265-2-007, Reliance PF Hip #7/17MM, 138 lots.

Why it was recalled

The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

Root cause (FDA determination)

Other

Action the firm took

A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.

Recalling firm

Firm

Stryker Howmedica Osteonics Corp.

Address

325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern

nationwide

Timeline

Recall initiated

2005-08-24

Posted by FDA

2005-11-01

Terminated

2006-04-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41811. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.