Recall Z-2116-2009 ยท HSB Rod, Fixation, Intramedullary And Accessories
EBI, L.P.
Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
| Date | Sep 21, 2009 (initiated Mar 27, 2009) |
| Status | Terminated |
| Reason | Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. |
| Root cause | Nonconforming Material/Component |
| Action | Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions. |
| Quantity | 5 |
| Distribution | Worldwide Distribution -- USA and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982953 | TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES Biomet, Inc., Oct 21, 1998 |