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BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF… recallZ-1151-2010 · Biomet Microfixation, Inc. · initiated Oct 6, 2009

Terminated All recalls posted in March 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

Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.

FDA root cause category: Process control

What the company is doing

Biomet Microfixation Issued an "Urgent Medical Device Recall Notice". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425. For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Recall details

Recall number
Z-1151-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 6, 2009
Posted by the FDA
Mar 17, 2010
Recalling firm
Biomet Microfixation, Inc.
Quantity
831 screws
Product code
JEY
FDA submissions
K953385
Distribution
Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.

Product description

BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed.

Code information (models, lots, serial numbers)

Lot Numbers: 813480, 114360, 498480, 753270, WL2340 and 031830.

Other devices under the same FDA submission

41 devices cleared under K953385 — 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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