Recall Z-0595-2009 ยท LYT Fixation Accessory
Ossur
Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS
| Date | Jan 2, 2009 (initiated Sep 26, 2008) |
| Status | Terminated |
| Reason | Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. |
| Root cause | Packaging process control |
| Action | Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does n |
| Quantity | 3 pouches (4 pins/pouch) = 12 pins |
| Distribution | Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA. |
| FDA record | Open on fda.gov |