9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extende
FDA device recall Z-1150-2017 · posted 2017-02-08 · Terminated
Recall details
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Reason for recall
- An incorrect sterility status on the label, non-sterile products labeled as sterile
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GCY
- Quantity affected
- 619
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
- Date initiated
- 2017-01-03
- Date posted
- 2017-02-08
- Date terminated
- 2017-07-27
- Location
- Freiburg, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TLS BULB DRAINAGE SYSTEM (K833586) | Porex Medical | 1984-01-30 |