FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
- Recall number
- Z-2139-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 40 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: 2080-0040; GAP PLATE SCREWS PTDMKE 27-Jun-2013 GAP PLATE SCREWS T0MMKE 01-Jul-2013 GAP PLATE SCREWS PT9MKE 02-Jul-2013 GAP PLATE SCREWS 34HMLE 09-Jul-2013 GAP PLATE SCREWS 34EMLE 14-Jul-2013 GAP PLATE SCREWS JKRMLE 23-Jul-2013 GAP PLATE SCREWS JKPMLE 23-Jul-2013 GAP PLATE SCREWS NL3MME 27-Aug-2013 GAP PLATE SCREWS NL6MME 27-Aug-2013 GAP PLATE SCREWS NL5MME 27-Aug-2013 GAP PLATE SCREWS NL4MME 28-Aug-2013 GAP PLATE SCREWS 7E4MNE 17-Sep-2013 GAP PLATE SCREWS 7E5MNE 17-Sep-2013 GAP PLATE SCREWS MERN50 05-Dec-2013 GAP PLATE SCREWS MERN4Y 05-Dec-2013 GAP PLATE SCREWS MET81P 18-Dec-2013 GAP PLATE SCREWS MET81T 18-Dec-2013 GAP PLATE SCREWS MET81V 18-Dec-2013 GAP PLATE SCREWS MET81R 22-Dec-2013 GAP PLATE SCREWS MET969 30-Dec-2013 GAP PLATE SCREWS MET967 30-Dec-2013 GAP PLATE SCREWS MET9H3 30-Dec-2013 GAP PLATE SCREWS MHA5LL 18-Jan-2014 GAP PLATE SCREWS MHA5LM 18-Jan-2014 GAP PLATE SCREWS MHA5LN 18-Jan-2014 GAP PLATE SCREWS MHA5LK 18-Jan-2014 GAP PLATE SCREWS MHA779 18-Jan-2014
- 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