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Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM… recallZ-0538-2010 · Biomet Microfixation, Inc. · initiated Nov 6, 2009

Terminated All recalls posted in December 2009

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 Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).

FDA root cause category: Process change control

What the company is doing

Consignees were notified of the recall by a combination of telephone calls, letters, and emails during the week of November 16, 2009. Customers were instructed to complete the Inventory Reconciliation Sheet and fax (1-904-741-9425) to the firm. Customers who further distributed the affected product was instructed to notify recipients of the recall. Direct questions about the recall to Biomet Microfixation, Inc. by calling 1-800-874-7711 or 1-904-741-4400, extension 468, Monday through Friday, 8 a.m. to 4 p.m. Eastern Standard Time.

Recall details

Recall number
Z-0538-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 6, 2009
Posted by the FDA
Dec 16, 2009
Recalling firm
Biomet Microfixation, Inc.
Quantity
283 pieces
Product code
HBE
FDA submissions
K062842
Distribution
Worldwide Distribution -- United States (including Puerto Rico), Australia, Brazil, Canada, Chile, Europe, France, Germany, Greece, Japan, Lebanon, Spain, and the United Arab Emirates.

Product description

Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Code information (models, lots, serial numbers)

Lots: 535933, 536306 and 537407.

Other devices under the same FDA submission

25 devices cleared under K062842 — 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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