Recall Z-1319-2010 ยท HWR Driver, Prosthesis
Biomet Microfixation, Inc.
BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.
| Date | Apr 11, 2010 (initiated Jan 15, 2010) |
| Status | Terminated |
| Reason | The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary. |
| Root cause | Device Design |
| Action | Consignees will be notified by letter on 01/15/2010 be either fax, email or mail. |
| Quantity | 73 |
| Distribution | US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.