Recall Z-0240-2023 ยท MBB Bone Cement, Antibiotic
Howmedica Osteonics Corp.
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
| Date | Nov 15, 2022 (initiated Oct 21, 2022) |
| Status | Open, Classified |
| Reason | Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010) |
| Root cause | Under Investigation by firm |
| Action | Stryker issued an An Urgent Medical Device Recall (UMDR) PFA 3082664 Letter issued by Sedgewick on 21/Oct/2022, via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if the device from the affected product table is at your facility. 3. Quarantine and discontinue use of the recalled device identified in the affected product table. 4 |
| Quantity | 90 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 Aap Biomaterials GmbH & Co. KG, Mar 7, 2013 |