Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 10, 2013
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no
The RPM of the Motor Handpiece may be less than 80,000 RPM.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
The Anspach Effort, Inc. recalled ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** P… - a moderate-severity action.
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** P… was recalled by The Anspach Effort, Inc. in July 10, 2013. Reason: The RPM of the Motor Handpiece may be less than 80,000 RPM.. Check the official notice for the remedy. Verify recall #Z-1659-2013 with the FDA Devices before acting.
The recall
The Anspach Effort, Inc. issued this moderate-severity FDA Devices recall-The RPM of the Motor Handpiece may be less than 80,000 RPM..
- Moderate
- severity level
- 61 units
- affected scope
- Class II
- classification
- July 10, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1659-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1659-2013) was formally reported on July 10, 2013, with the manufacturer initiating the action on June 24, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. The Anspach Effort, Inc. is listed as the recalling firm, operating out of Palm Beach Gardens, FL. Federal records list the affected scope as 61 units.
The documented reason for this recall is: The RPM of the Motor Handpiece may be less than 80,000 RPM. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
61 units
Related Recalls
6
3 from same agency
Product description
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
Reason for recall
The RPM of the Motor Handpiece may be less than 80,000 RPM.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1659-2013 |
| Date reported | July 10, 2013 |
| Date initiated | June 24, 2011 |
| Recalling firm | The Anspach Effort, Inc. |
| Firm location | Palm Beach Gardens, FL |
| Affected scope | 61 units |
| Distribution | Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey; |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1659-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).. Recalled by The Anspach Effort, Inc.. Units affected: 61 units.
Why was this product recalled? ▼
The RPM of the Motor Handpiece may be less than 80,000 RPM.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1659-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1659-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 10, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.