REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Recall
- Recall Number
- Z-0866-2009
- Event Number
- 50516
- Firm
- Biomet Microfixation, Inc.
- FEI Number
- 1032347
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 6, 2008
- Posted
- January 29, 2009
- Terminated
- September 11, 2009
- Address
- 1520 Tradeport Dr, Jacksonville, FL, 32218-2480
Description
REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
An IFU and correction letter will be issued to the field. Each distributor will receive instructions for delivering the correction letter to all customers. The customer letter will contain a reconciliation form to be returned once the customer receives the IFU for the twist drill. Contact Biomet Microfixation for additional information at 1-800-874-7711.
Distributed domestically throughout the U.S. Distributed internationally to Argentina, Australia, Canada, Columbia, Hong Kong, Japan, Mexico, New Zealand, Puerto Rico, Taiwan, Thailand, Denmark, France, Netherlands, Greece, Italy, Norway, Finland, Spain, Czech Republic, and Venezuela.
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