FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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
- Recall number
- Z-2138-2009
- Recalling firm
- Stryker 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
- Status
- Terminated
- Initiated
- 2009-06-26
- Posted
- 2009-09-14
- Terminated
- 2010-07-27
- Reason
- 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
- 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
- 51,113 total - all sizes.
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K873251"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28