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Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only recallZ-0779-2014 · The Anspach Effort, Inc. · initiated May 6, 2013

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

Product did not reach expected sterility assurance level

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: [email protected]. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: [email protected].

Recall details

Recall number
Z-0779-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 6, 2013
Posted by the FDA
Jan 16, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
183
Product code
ERL
FDA submissions
K011444, K965080
Distribution
Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.

Product description

Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

Code information (models, lots, serial numbers)

ALL LOTS

Other devices under the same FDA submission

31 devices cleared under K011444, 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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