FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 50 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
- Recall number
- Z-2141-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 50 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: 2080-0050; GAP PLATE SCREWS XEHMKE 06-Jul-2013 GAP PLATE SCREWS K1RMLE 22-Jul-2013 GAP PLATE SCREWS K1JMLE 23-Jul-2013 GAP PLATE SCREWS 7DYMNE 16-Sep-2013 GAP PLATE SCREWS 7E0MNE 16-Sep-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