FDA Device recall Z-0165-2015
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corru…
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corru… by Zimmer Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0165-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Surgical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electr…89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece 222805 222806 222807 222808 222809 222810 222811 222812 222813 222814 222945 222946 222947 222948 222949 222950 222951 222952 222953 222955 222956 223077 223078 223079 223080 223081 223082 223083 223084 223085 223086 223199 223200 223201 223202 223203 223204 223205 223206 223207 223208 223209 223210 223401 223403 223404 223405 223406 223407 223408 223409 223410 223411 223730 223731 223732 223733 223734 223735 223736 223737 223738 223739 223804 224187 224188 224189 224190 224191 224192 224193 224194 224195 224196 224197 224198 224199 224200 224201 224202 224203 224204 224205 224206 224207 224208 224209 224210 224393 224394 224395 224396 224397 224398 224399 224400 224402 224625 224626 224627 224628 224629 224630 224631 224632 22 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0165-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.