—#107822

Product

Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle, neck length ranges and a C-Taper head to provide the surgeon with the ability to restore near anatomic head position for proper leg length and biomechanical function. Restoration HA femoral component accepts C-Taper heads, 22mm, 26mm, 28mm, and 32mm with a negative 5mm to positive 10mm offsets.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K951671
Affected lot / code info: 510(K) #K951671 Catalog #: S-2653-0812-L Affected Lot Codes 45041401 49051101 50024801 21578001 26464501A 49051101A 26464501C 97161201 54123101A 45041401C 18826701 49051101C 49760101A 49051101D 21473201 49051101E 54123101C 54008001C 50024801C 50024801D 97161201A 49760101C 50024801E 21473201A RK8MKE RK9MKE T7DMKE MHLL7Y MHM0DA MHJRE8-R

Why it was recalled

An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.

Root cause (FDA determination)

Error in labeling

Action the firm took

Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution and the country of Canada.

Timeline

Recall initiated: 2011-10-27
Posted by FDA: 2012-05-29
Terminated: 2013-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.