Z-0453-2016Class II

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in...

Name: Z-0453-2016 Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in...
Creator: Zimmer, Inc.
Published: 2015-11-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-11-10 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland on 2015-11-10. FDA classified it as Class II and gives the reason as "The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0453-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2015-12-21
Terminated: 2016-02-19
Recalling firm: Zimmer GmbH
Product: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Product code: HAB Saw, Powered, And Accessories
Reason for recall: The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Model # 01-8507-400-10 & Model # 89-8507-400-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0452-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21
Z-0453-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21

Product code HAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)