FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
- Recall number
- Z-0811-2020
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
- Status
- Terminated
- Initiated
- 2019-11-07
- Posted
- not on file
- Terminated
- 2020-08-31
- Reason
- May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
- Root cause
- Employee error
- Action
- Stryker issued Urgent Medical Device Recall - PFA 2147264 letter dated November 7, 2019) to US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. Letter states reason for recall, health risk and action to take: Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-350-3903 or email to StrykerOrtho6467@stericycle.com within 5 Days. 5.Hospitals Only: Return all affected product available at your location to your local branch office. 6.Branches/Agencies: Return all affected product returned by the hospital and/or available at your location to the following address: Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430, PFA #2147264. Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to
- Quantity
- 20 units
- Distribution
- CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan
- Lot, serial or model codes
- Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501
- 510(k) numbers
- ["K974685"]
- PMA numbers
- not on file
- Product code
- JDI
- 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