Z-2138-2009

Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica...

Name: Z-2138-2009 Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-06-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-06-26 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 on 2009-06-26. The reason FDA records is "Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2138-2009
Status: Terminated
Initiated: 2009-06-26
Posted: 2009-09-14
Terminated: 2010-07-27
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
Quantity in commerce: 51,113 total - all sizes.
Distribution: Worldwide Distribution
Product codes and lots: Catalog number: 2080-0035; GAP PLATE SCREWS PTJMKE 29-Jun-2013 GAP PLATE SCREWS PTLMKE 29-Jun-2013 GAP PLATE SCREWS T0RMKE 06-Jul-2013 GAP PLATE SCREWS T0PMKE 06-Jul-2013 GAP PLATE SCREWS T0VMKE 06-Jul-2013 GAP PLATE SCREWS J47MLE 21-Jul-2013 GAP PLATE SCREWS J44MLE 21-Jul-2013 GAP PLATE SCREWS J45MLE 22-Jul-2013 GAP PLATE SCREWS J48MLE 22-Jul-2013 GAP PLATE SCREWS 4P9MNE 10-Sep-2013 GAP PLATE SCREWS 4PDMNE 11-Sep-2013 GAP PLATE SCREWS 4PAMNE 11-Sep-2013 GAP PLATE SCREWS 4P8MNE 11-Sep-2013 GAP PLATE SCREWS MERN4W 05-Dec-2013 GAP PLATE SCREWS MERN4X 05-Dec-2013 GAP PLATE SCREWS METD97 21-Dec-2013 GAP PLATE SCREWS METDE0 21-Dec-2013 GAP PLATE SCREWS METDDX 21-Dec-2013 GAP PLATE SCREWS METDE3 21-Dec-2013 GAP PLATE SCREWS METDE6 21-Dec-2013 GAP PLATE SCREWS METDE2 30-Dec-2013

Product code MEH

K873251Class IIOmnifit Bone ScrewOsteonics Corp. / cleared 1987-09-18

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)