FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 20 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
- Recall number
- Z-2135-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 20 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: 2080-0020; GAP PLATE SCREWS T0WMKE 01-Jul-2013 GAP PLATE SCREWS T0XMKE 02-Jul-2013 GAP PLATE SCREWS T10MKE 02-Jul-2013 GAP PLATE SCREWS T0YMKE 02-Jul-2013 GAP PLATE SCREWS 22RMLE 07-Jul-2013 GAP PLATE SCREWS 229MLE 07-Jul-2013 GAP PLATE SCREWS 22PMLE 08-Jul-2013 GAP PLATE SCREWS D01MLE 21-Jul-2013 GAP PLATE SCREWS AYYMLE 23-Jul-2013 GAP PLATE SCREWS PLAMME 27-Aug-2013 GAP PLATE SCREWS PN2MME 27-Aug-2013 GAP PLATE SCREWS PL8MME 28-Aug-2013 GAP PLATE SCREWS PL9MME 28-Aug-2013 GAP PLATE SCREWS PN1MME 28-Aug-2013 GAP PLATE SCREWS 7DXMNE 16-Sep-2013 GAP PLATE SCREWS MET9H4 18-Dec-2013 GAP PLATE SCREWS MET9X8 18-Dec-2013 GAP PLATE SCREWS MET9X7 22-Dec-2013 GAP PLATE SCREWS METL9Y 28-Dec-2013 GAP PLATE SCREWS METLA0 30-Dec-2013 GAP PLATE SCREWS MET9H5 30-Dec-2013 GAP PLATE SCREWS MET9X9 30-Dec-2013 GAP PLATE SCREWS MET9XA 30-Dec-2013 GAP PLATE SCREWS MHA4YT 14-Jan-2014 GAP PLATE SCREWS MHA4YR 18-Jan-2014 GAP PLATE SCREWS MHA55K 18-Jan-2014 GAP PLATE SCREWS MHA55L 18-Jan-2014 GAP PLATE SCREWS MHA55H 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