Z-1677-2012

Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate...

Name: Z-1677-2012 Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-10-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-10-27 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA... on 2011-10-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1677-2012
Status: Terminated
Initiated: 2011-10-27
Posted: 2012-05-29
Terminated: 2013-08-22
Recalling firm: Howmedica Osteonics Corp
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.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 31 Units
Distribution: Nationwide Distribution and the country of Canada.
Product codes and lots: 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

Product code MEH

K951671Class IIOsteonics Restoration Monolithic II Slotted Hip Stem SeriesOsteonics Corp. / cleared 1995-09-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)