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Terminated

Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.

FDA Recall Z-1480-2009 · Posted 2009-06-30

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDZ
Date Initiated2009-04-09
Date Terminated2010-10-06
Product Quantity250

Reason for Recall

The package may contain two short mixing rods instead of one long and one short rod.

Firm Action

Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product. Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.

Official Source

View FDA Recall →

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

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