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Foot Pedal, Foot Control for SC2000 and SC2100 Powered… recallZ-0083-2010 · The Anspach Effort, Inc. · initiated Aug 13, 2009

Terminated All recalls posted in October 2009

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. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal

FDA root cause category: Device Design

What the company is doing

Anspach issued an "Urgent Product Removal" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm. For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.

Recall details

Recall number
Z-0083-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 13, 2009
Posted by the FDA
Oct 28, 2009
Recalling firm
The Anspach Effort, Inc.
Quantity
14
Product code
HBE
FDA submissions
K011444, K080802
Distribution
Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).

Product description

Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. Indicated to cut and shape bone including bones of the spine and cranium.

Code information (models, lots, serial numbers)

EMAX2-FP Serial Numbers: C26302250301, C26302250302, C26302250303, C26302250304, 5044044307, 31495607, 32380602, 31832209, 31832202 and 32366805; and  EPLUS-FP Serial Numbers: C26302200804 , C26302200802, C27302221701 and C08301701901.

Other devices under the same FDA submission

40 devices cleared under K011444, 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.

Sources and updates

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