Skip to content

2.0/1.0 4 hole long plate (titanium plate ).Lot 120150 recallZ-0108-2011 · Biomet Microfixation, Inc. · initiated Aug 31, 2010

Terminated All recalls posted in October 2010

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

Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).

FDA root cause category: Other

What the company is doing

Biomet Microfixation sent URGENT MEDICAL DEVICE RECALL NOTICES dated August 31, 2010 to its customers and distributors, identifying the affected product and actions to be taken by customers. Customers were requested to check their inventory for product and return any affected product to Biomet Microfixation. Customer questions or concerns should be directed to Laura Sabo, VP Global QA/RA at 904-741-4500.

Recall details

Recall number
Z-0108-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 31, 2010
Posted by the FDA
Oct 20, 2010
Recalling firm
Biomet Microfixation, Inc.
Quantity
56
Product code
JEY
FDA submissions
K854886
Distribution
Worldwide Distribution: USA including states of Hawaii and Kansas, and the countries of Australia, Denmark, Italy, Jordan, and South Africa.

Product description

2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com. (3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086

Code information (models, lots, serial numbers)

Lot 120150.

Other devices under the same FDA submission

7 devices cleared under K854886 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page