FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
- Recall number
- Z-0453-2016
- Recalling firm
- Zimmer, Inc.
- Product
- Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
- Status
- Terminated
- Initiated
- 2015-11-10
- Posted
- 2015-12-21
- Terminated
- 2016-02-19
- Reason
- The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
- Root cause
- Device Design
- Action
- Zimmer sent an Urgent Medical Device Correction letter dated November 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Review this notification. 2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities. 3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified. 4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday. Zimmer instructed their direct customers that they will upgrade the device with the new electronic during their annual preventative maintenance activities. Until the new upgrade is installed, the firm instructed their customers to follow the Instructions for Use.
- Quantity
- 89 units
- Distribution
- US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.
- Lot, serial or model codes
- Model # 01-8507-400-10 & Model # 89-8507-400-10
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAB
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28