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Anspach Single Use, Sterile Bone Cutting Burrs recallZ-1008-2007 · The Anspach Effort, Inc. · initiated May 18, 2007

Terminated All recalls posted in July 2007

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 The Anspach Effort, 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 white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.

Recall details

Recall number
Z-1008-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 18, 2007
Posted by the FDA
Jul 11, 2007
Recalling firm
The Anspach Effort, Inc.
Quantity
1,962,123
Product code
HBB
FDA submissions
K011444, K061297, K955084, K965080
Distribution
World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.

Product description

Anspach Single Use, Sterile Bone Cutting Burrs

Code information (models, lots, serial numbers)

All cutting burrs packaged with an expiration date between June 2008 and august 2011.

Other devices under the same FDA submission

31 devices cleared under K011444, K061297, K955084, K965080 — 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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