UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric… — Class II medical device recall Z-0165-2015
Terminated recall by Zimmer Surgical Inc, reported 2014-11-12, distributed nationwide. Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by i
| Recall number | Z-0165-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2014-10-31 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 828 |
| Reason classes | device malfunction |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0165-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.