FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
- Recall number
- Z-0388-2013
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
- Status
- Terminated
- Initiated
- 2012-08-17
- Posted
- 2012-11-19
- Terminated
- 2014-04-10
- Reason
- Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
- Root cause
- Mixed-up of materials/components
- Action
- The firm, Stryker Orthopaedics, notified Domestic locations of this action by e-mail on August 6, 2012 and foreign locations of this action by e-mail on August 7, 2012. Stryker follow-up by sending an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated August 17, 2012 to their consignees/customers via Fed Ex with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and return affected product to Attn: Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430 (attach fluorescent orange sticker and mark box with words "Product Recall"), or contact your Stryker Sales Representative to arrange for return of the product ,and complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.
- Quantity
- Approximately 358 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.
- Lot, serial or model codes
- Catalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT Ref 2030-6535-1
- 510(k) numbers
- ["K894124"]
- 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