Recall Z-0736-2023 ยท LOD Bone Cement
Howmedica Osteonics Corp.
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
| Date | Dec 20, 2022 (initiated Nov 7, 2022) |
| Status | Open, Classified |
| Reason | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate. |
| Root cause | Under Investigation by firm |
| Action | Update 12/15/22: An UPDATED Urgent Medical Device Correction PFA 3140774 was issued to impacted customers in Turkey only on December 15, 2022. Letter states: 1. Please inform users of this UPDATE Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed UPDATE Urgent Medical Device Correction Business Reply Form. Potent |
| Quantity | 2085 units |
| Distribution | International distribution in the country of Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002652 | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII Stryker Corp., Jan 26, 2001 |