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U.S. Department of Health and Human Services

Class 2 Device Recall REF XMAXXMax Handpiece

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 Class 2 Device Recall REF XMAXXMax Handpiecesee related information
Date Initiated by FirmApril 25, 2013
Date PostedJanuary 09, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall NumberZ-0655-2014
Recall Event ID 66323
510(K)NumberK965080 
Product Classification Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Product***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Code Information Serial Number G11307654403
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information ContactDenise DeLuigi
561-494-3711
Manufacturer 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..
FDA Determined
Cause 2		Component design/selection
ActionThe 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 Commerce976
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ERL
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