FDA Medical Device Recalls (openFDA)
Biomet Microfixation, Inc.: Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.
- Recall number
- Z-1872-2008
- Recalling firm
- Biomet Microfixation, Inc.
- Product
- Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.
- Status
- Terminated
- Initiated
- 2008-03-19
- Posted
- 2008-09-16
- Terminated
- 2009-09-11
- Reason
- The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).
- Root cause
- Packaging process control
- Action
- On 3/19/08 the firm issued an Urgent Medical Device Recall Notice to its consignees by certified letters with return receipt. All returned products will be held in quarantine until final disposition is determined. If you have any questions contact Rachel Osbeck at 1-800-874-7711 or (904) 741-4400 ext 448.
- Quantity
- 117
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of NC, MI, TX, GA, HI, OK, IN and CA, and countries of Denmark, Germany, Mexico, Italy, Brazil, Japan, Canada, South Africa, China and the Philippines.
- Lot, serial or model codes
- Part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. Lot numbers: 898240, 898330, 898250, 898350, 898320, 951140, 868920, and 978810.
- 510(k) numbers
- ["K955729","K980927"]
- PMA numbers
- not on file
- Product code
- JEY
- 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