Recall Z-0467-2014 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
| Date | Dec 7, 2013 (initiated Oct 25, 2013) |
| Status | Terminated |
| Reason | Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. |
| Root cause | Packaging process control |
| Action | Stryker sent an e-mail to their domestic locations on 10/11/2013. Notification letters and product accountability forms were sent via Fed Ex on 10/25/2013 with return receipt to branches/agencies and hospital risk management, chief of orthopaedics and surgeons. |
| Quantity | 20 units |
| Distribution | Nationwide Distribution including states: AL, GA, IL, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120578 | ACCOLADE II HIP STEM Howmedica Osteonics, Mar 29, 2012 |