FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixtures that may be used during knee and hip replacement procedures.
- Recall number
- Z-2127-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixtures that may be used during knee and hip replacement procedures.
- 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: 2029-5525-1; 5.5 CANCELLOUS BONE SCREW 25mm N0PMKE 24-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm N0NMKE 24-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm N0MMKE 24-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm N0RMKE 25-Jun-2013 5.5 CANCELLOUS BONE SCREW 25mm H1NMLE 21-Jul-2013 5.5 CANCELLOUS BONE SCREW 25mm JLWMLE 23-Jul-2013 5.5 CANCELLOUS BONE SCREW 25mm EL5MME 24-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm EMVMME 24-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm KW8MME 24-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm EL6MME 25-Aug-2013 5.5 CANCELLOUS BONE SCREW 25mm MER1AN 11-Nov-2013 5.5 CANCELLOUS BONE SCREW 25mm MER1AM 12-Nov-2013 5.5 CANCELLOUS BONE SCREW 25mm MET3JH 10-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET3JE 11-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6KM 14-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6AR 14-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6KL 14-Dec-2013 5.5 CANCELLOUS BONE SCREW 25mm MET6LL 14-Dec-2013
- 510(k) numbers
- ["K873251"]
- PMA numbers
- not on file
- Product code
- HWC
- 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