Recall Z-0864-2009
Biomet Microfixation, Inc. · initiated August 6, 2008
Product
REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25") (WXL), Polypropylene, Radel. 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.
Codes / lots: Lot Numbers 026660, 044820, 044830, 044900, 069630, 119940, 175710, 207320, 286830, 323270, 373220, 375190, 393190, 396390, 464030, 620270, and 718350.
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0864-2009
- Initiated
- August 6, 2008
- Posted by FDA
- January 29, 2009
- Terminated
- September 11, 2009
- Quantity
- 98
- Distribution
- 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.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0865-2009 | REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |
| Z-0866-2009 | REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C.…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |
| Z-0867-2009 | REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9")…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |