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ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx… recallZ-1887-2014 · The Anspach Effort, Inc. · initiated Nov 28, 2012

Class II Terminated All recalls posted in June 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

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

FDA root cause category: Process design

What the company is doing

The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.

Recall details

Recall number
Z-1887-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 28, 2012
Posted by the FDA
Jun 25, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
6
Product code
HBE
FDA submissions
K080802
Distribution
Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

Product description

ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Code information (models, lots, serial numbers)

Part Number: 98-0016; Serial Numbers: 200008201, 200008202, 200008203, 200008204, 200008205, 200008206.

Other devices under the same FDA submission

11 devices cleared under K080802 — 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 64247).

Sources and updates

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