FDA Medical Device Recalls (openFDA)
Biomet Microfixation, Inc.: REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. 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 number
- Z-0865-2009
- Recalling firm
- Biomet Microfixation, Inc.
- Product
- REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. 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.
- Status
- Terminated
- Initiated
- 2008-08-06
- Posted
- 2009-01-29
- Terminated
- 2009-09-11
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 285
- 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.
- Lot, serial or model codes
- Lot Numbers: 056960, 060930, 071130, 085650, 155540, 181390, 2247100, 248520, 368120, 584110, 716090, 716100, 716110, 717510, 782200, 851620, 990550, and 999999.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28