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REF S-3D*** 3mm Diamond Ball recallZ-1377-2013 · The Anspach Effort, Inc. · initiated Mar 4, 2011

Class II Terminated All recalls posted in May 2013

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

Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

FDA root cause category: Labeling mix-ups

What the company is doing

Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.

Recall details

Recall number
Z-1377-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 4, 2011
Posted by the FDA
May 24, 2013
Recalling firm
The Anspach Effort, Inc.
Quantity
1,827 burrs
Product code
HBE
FDA submissions
K113476
Distribution
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.

Product description

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

Code information (models, lots, serial numbers)

Lots numbers: D433040800, D403040236, D383039472.

Other devices under the same FDA submission

47 devices cleared under K113476 — 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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