Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 12, 2014
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Surgical Inc recalled UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is pac… - a moderate-severity action.
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is pac… was recalled by Zimmer Surgical Inc in November 12, 2014. Reason: Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by…. Check the official notice for the remedy. Verify recall #Z-0165-2015 with the FDA Devices before acting.
The recall
Zimmer Surgical Inc issued this moderate-severity FDA Devices recall-Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by….
- Moderate
- severity level
- 828 units
- affected scope
- Class II
- classification
- November 12, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0165-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0165-2015) was formally reported on November 12, 2014, with the manufacturer initiating the action on October 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Surgical Inc is listed as the recalling firm, operating out of Dover, OH. Federal records list the affected scope as 828.
The documented reason for this recall is: Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY.. 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
828
Related Recalls
6
3 from same agency
Product description
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Reason for recall
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0165-2015 |
| Date reported | November 12, 2014 |
| Date initiated | October 6, 2014 |
| Recalling firm | Zimmer Surgical Inc |
| Firm location | Dover, OH |
| Affected scope | 828 |
| Distribution | US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY. |
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-0165-2015) 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? ▼
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.. Recalled by Zimmer Surgical Inc. Units affected: 828.
Why was this product recalled? ▼
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 12, 2014. Severity: Moderate. Recall number: Z-0165-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0165-2015) 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 November 12, 2014. 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.