—#178104

Product

Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K974685
Affected lot / code info: Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan

Timeline

Recall initiated: 2019-11-07
Terminated: 2020-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178104. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.