CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report
***REF Micromax***microMax Handpiece***Rx Only***Manufacturer recalled
The Anspach Effort is recalling ***REF Micromax***microMax Handpiece***Rx Only***Manufacturer: The, distributed nationwide in the US. The recall was initiated on 25 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0656-2014
- FDA event ID
- 66323
- Recalling firm
- The Anspach Effort, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2013
- FDA classified
- 9 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2013 | Recall initiated by company | |
| 9 Jan 2014 | Classified by FDA | +259 days |
| 15 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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..
Product as listed by the FDA
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it 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..
Which lots are affected?
Serial Number MM900
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 66323This product is part of a recall event; the main page for the event is ***REF Imri-motor***iMRI Handpiece. Use with iMRI System Only***Rx recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ***REF Imri-motor***iMRI Handpiece. Use with iMRI System Only***Rx recalled | The Anspach Effort | Other | Nationwide | |
| CLASS II | ***REF Xmax***XMax Handpiece***Rx Only***Manufacturer: The Anspach recalled | The Anspach Effort | Other | Nationwide | |
| CLASS II | ***REF Blackmax-n***Swivel/Angle Motor Assembly***Rx Only***The recalled | The Anspach Effort | Other | Nationwide |
More recalls from The Anspach Effort
All 260| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adult Craniotome recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Rotating Craniotome Attachment recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Craniotome, Thin Foot Plate Attachment recalled | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Adult Rotating Craniotome Attachment recalled by The Anspach Effort | The Anspach Effort | Processing Deviation | Nationwide |
| Device | CLASS II | Large Craniotome Attachment Use with XMax¿, microMax recalled | The Anspach Effort | Processing Deviation | Nationwide |
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