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16cm Minimally Invasive Attachment. For use with Motor… recallZ-1037-2015 · The Anspach Effort, Inc. · initiated Dec 10, 2014

Class II Terminated All recalls posted in February 2015

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

Customer complaint indicating the color bands on the MIA16-G1 were not correct.

FDA root cause category: Environmental control

What the company is doing

Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.

Recall details

Recall number
Z-1037-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 10, 2014
Posted by the FDA
Feb 2, 2015
Recalling firm
The Anspach Effort, Inc.
Quantity
8
Product code
HBC
FDA submissions
K133604
Distribution
US Distribution to the states of: NC and CA., and Internationally to Switzerland.

Product description

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

Code information (models, lots, serial numbers)

Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.

Other devices under the same FDA submission

18 devices cleared under K133604 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page