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AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD… recallZ-0829-2014 · The Anspach Effort, Inc. · initiated Mar 31, 2011

Class II Terminated All recalls posted in January 2014

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

Cutter was longer than was stated on the label

FDA root cause category: Pending

What the company is doing

Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887. For questions regarding this recall, call 800-327-6887.

Recall details

Recall number
Z-0829-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 31, 2011
Posted by the FDA
Jan 27, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
599 cutting burs
Product code
HBC
FDA submissions
K011444, K974025
Distribution
Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.

Product description

AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

Code information (models, lots, serial numbers)

Lot #'s: D293037349, D323038110 and D363039140

Other devices under the same FDA submission

29 devices cleared under K011444, K974025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67176).

Sources and updates

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