REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The… recallZ-0655-2014 · The Anspach Effort, Inc. · initiated Apr 25, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- 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.
- 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.
- 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 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 root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0655-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 25, 2013
- Posted by the FDA
- Jan 9, 2014
- Recalling firm
- The Anspach Effort, Inc.
- Quantity
- 976
- Product code
- ERL
- FDA submissions
- K965080
- 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 description
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Code information (models, lots, serial numbers)
Serial Number G11307654403
Other devices under the same FDA submission
2 devices cleared under K965080 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
Other products in the same recall event
The FDA groups related products into one recall event (event 66323).
- Z-0656-2014 · Terminated***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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