FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
- Recall number
- Z-2810-2015
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
- Status
- Terminated
- Initiated
- 2015-06-25
- Posted
- 2015-09-23
- Terminated
- 2017-08-30
- Reason
- it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
- Root cause
- Nonconforming Material/Component
- Action
- Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
- Quantity
- 16 units
- Distribution
- Distributed in WI.
- Lot, serial or model codes
- Lot Code 3Y0KHP
- 510(k) numbers
- ["K033716"]
- PMA numbers
- not on file
- Product code
- LPH
- 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