Recall Z-2164-2010 ยท LXH Orthopedic Manual Surgical Instrument
Encore Medical, Lp
MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.
| Date | Aug 2, 2010 (initiated Apr 26, 2010) |
| Status | Terminated |
| Reason | A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks. |
| Root cause | Component design/selection |
| Action | An "Urgent Field Safety Notice" Letter dated May 20, 2010, was sent to the customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to locate, inspect and verify the quantity still in their possession, complete and return the field safety notice response page to Beth Onderlinde at beth.onderlinde@djosurgical.com or fax to 512-834-6313 by June 7, 2010, (completion of form is mandatory), and identify and inform customers that they may have distributed/sold product to, of the notice. The customer was also instructed to please inspect |
| Quantity | 729 and 67 specials |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.