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.
This recall has been terminated (originally issued April 11, 2010).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- January 15, 2010
- Posted
- April 11, 2010
- Terminated
- May 14, 2010
- Recall Number
- Z-1319-2010
- Quantity
- 73
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa
Lot / Code Info
Lots: 459660, 478770, 530640.
Root Cause
Device Design
Action Taken
Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.
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