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Terminated

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.

FDA Recall Z-1319-2010 · Posted 2010-04-11

Recalling FirmBiomet Microfixation, Inc.
Recall StatusTerminated
Product CodeHWR
Date Initiated2010-01-15
Date Terminated2010-05-14
Product Quantity73

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.

Firm Action

Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.

Root Cause

Device Design

Distribution Pattern

US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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