Recall Z-1676-2013 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Zimmer, Inc.
Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
| Date | Jul 10, 2013 (initiated Jun 11, 2013) |
| Status | Terminated |
| Reason | The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices. |
| Root cause | Packaging process control |
| Action | Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email |
| Quantity | 1 |
| Distribution | Nationwide Distribution including IL and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110791 | BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION Zimmer, Inc., Sep 2, 2011 |