—#122060

Product

***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

FDA product code: ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K965080
Affected lot / code info: Serial Number G11307654403

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

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.

Timeline

Recall initiated: 2013-04-25
Posted by FDA: 2014-01-09
Terminated: 2015-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.