Z-0657-2014 Class II Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-0657-2014 was initiated by The Anspach Effort, Inc. on Apr 25, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jul 20, 2015). Affected quantity: 12.

Recall Details

Product Type
Devices
Report Date
Jan 15, 2014
Initiation Date
Apr 25, 2013
Termination Date
Jul 20, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12

Product Description

***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

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..

Distribution Pattern

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.

Code Information

Serial Number F37306977201

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0657-2014
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.