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U.S. Department of Health and Human Services

Class 2 Device Recall Lactosorb Trauma Plating System

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 Class 2 Device Recall Lactosorb Trauma Plating Systemsee related information
Date Initiated by FirmMarch 19, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on September 11, 2009
Recall NumberZ-1872-2008
Recall Event ID 48461
510(K)NumberK955729 K980927 
Product Classification Bone Plate - Product Code JEY
ProductLactosorb 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.
Code Information 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.
FEI Number 1032347
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact
904-741-4400
Manufacturer Reason
for Recall		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).
FDA Determined
Cause 2		Packaging process control
ActionOn 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 in Commerce117
DistributionClass 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JEY
510(K)s with Product Code = JEY
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