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Lactosorb Trauma Plating System, part numbers: 915-2100… recallZ-1872-2008 · Biomet Microfixation, Inc. · initiated Mar 19, 2008

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet Microfixation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1872-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 19, 2008
Posted by the FDA
Sep 16, 2008
Recalling firm
Biomet Microfixation, Inc.
Quantity
117
Product code
JEY
FDA submissions
K955729, K980927
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 description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

21 devices cleared under K955729, K980927 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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