Z-0657-2014Class II

REF IMRI-MOTORiMRI Handpiece. Use with iMRI System OnlyRx OnlyManufacturer: The Anspach Effort...

Name: Z-0657-2014 ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort...
Creator: The Anspach Effort, Inc.
Published: 2013-04-25
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2013-04-25 / Terminated / root cause: design

FDA source

The Anspach Effort, Inc. began a recall of ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone on 2013-04-25. FDA classified it as Class II and gives the reason as "The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0657-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Posted: 2014-01-09
Terminated: 2015-07-20
Recalling firm: The Anspach Effort, Inc.
Product: ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Anspach sent an "URGENT" Medical Devics Removal" letter dated April 24, 2013, to its customers. Customer Immediate Actions: 1. Screen your current inventory and return all Anspach Pneumatic Drill System without a pressure Relief valve (PRV) from your inventory. 2. If you have any product listed on the attached form to arrange for immediate return and replacements. 3. complete the attached Customer Reply form indicating the product being returned. 4. Upon receipt of a replacement product, equipment being returned must be received by Anspach within 10 business days of the replacement request. Should you have any queries, please contact Anspach Product Support at (800) 327-6887.
Quantity in commerce: 12
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.
Product codes and lots: Serial Number F37306977201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0657-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0654-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0655-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0656-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09
Z-0657-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09

Product code HBB

K061297Class IIAnspach Imri Safe Surgical Drill SystemThe Anspach Effort, Inc. / cleared 2007-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)