BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part N
FDA device recall Z-1319-2010 · posted 2010-04-11 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- 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.
- Action taken
- Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWR
- Quantity affected
- 73
- Distribution
- US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa
- Date initiated
- 2010-01-15
- Date posted
- 2010-04-11
- Date terminated
- 2010-05-14
- Location
- Jacksonville, FL
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