Z-1872-2008

Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105...

Name: Z-1872-2008 Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105...
Creator: Biomet Microfixation, Inc.
Published: 2008-03-19
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2008-03-19 / Terminated / root cause: packaging

FDA source

Biomet Microfixation, Inc. began a recall of 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... on 2008-03-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1872-2008
Status: Terminated
Initiated: 2008-03-19
Posted: 2008-09-16
Terminated: 2009-09-11
Recalling firm: Biomet Microfixation
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.
Product code: JEY Plate, Bone
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).
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code JEY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)