Recall Z-1150-2017 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Stryker Leibinger GmbH & Co. KG
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
| Date | Feb 8, 2017 (initiated Jan 3, 2017) |
| Status | Terminated |
| Reason | An incorrect sterility status on the label, non-sterile products labeled as sterile |
| Root cause | Labeling mix-ups |
| Action | Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558. |
| Quantity | 619 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833586 | TLS BULB DRAINAGE SYSTEM Porex Medical, Jan 30, 1984 |