Recall Z-0508-2012 ยท HXK Holder, Needle; Orthopedic
DePuy Orthopaedics, Inc.
Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.
| Date | Jan 11, 2012 (initiated Nov 8, 2011) |
| Status | Terminated |
| Reason | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt. |
| Root cause | Component change control |
| Action | On 11/9/2011 DePuy sent "Medical Device Recall Notice" letters to Distributors and to direct account hospitals. Recall notices included instructions to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN via distributors and sales representatives. The product is going to be discontinued and no reconditioning or reworking for the product is planned. For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - pm EST.) |
| Quantity | 890 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860018 | FISCHER WIRE/PIN CLAMP Buckman Co., Inc., Feb 7, 1986 |